跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01999400
NCT01999400已完成不适用

Correlation of Mesalamine Pharmacokinetics With Local Availability

University of Michigan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The AUC of Mesalamine in Plasma
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.

详细描述

This study evaluated the pharmacokinetics of mesalamine and its major metabolite of mesalamine known as N-acetyl-mesalamine in plasma. Mesalamine is available in different formulations that control the rate at which they are released in the gastrointestinal tract. Three formulations of mesalamine, Pentasa, Apriso, and Lialda, were studied in the crossover phase, while an oral solution formulation of mesalamine was studied in the single-arm phase. Each subject participated in a crossover phase study with one of the three formulations assigned at random using block randomization. Then the subject entered the single-arm phase study. After participation in one crossover phase study and one single-arm phase study, the subject could opt to participate in crossover phase studies using the other formulations also chosen at random until all three formulations were studied. The single-arm phase study was not repeated on returning subjects who participated in more than one crossover phase study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1: Pentasa then Delzicol then Apriso then Lialda

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 1: Pentasa then Delzicol then Apriso then Lialda

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 1: Pentasa then Delzicol then Apriso then Lialda

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 1: Pentasa then Delzicol then Apriso then Lialda

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

Arm 2: Pentasa then Delzicol then Lialda then Apriso

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 2: Pentasa then Delzicol then Lialda then Apriso

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 2: Pentasa then Delzicol then Lialda then Apriso

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 2: Pentasa then Delzicol then Lialda then Apriso

Experimental
  1. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

Arm 3: Apriso then Delzicol then Pentasa then Lialda

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 3: Apriso then Delzicol then Pentasa then Lialda

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 3: Apriso then Delzicol then Pentasa then Lialda

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 3: Apriso then Delzicol then Pentasa then Lialda

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

Arm 4: Apriso then Delzicol then Lialda then Pentasa

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 4: Apriso then Delzicol then Lialda then Pentasa

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 4: Apriso then Delzicol then Lialda then Pentasa

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 4: Apriso then Delzicol then Lialda then Pentasa

Experimental
  1. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

Arm 5: Lialda then Delzicol then Pentasa then Apriso

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 5: Lialda then Delzicol then Pentasa then Apriso

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 5: Lialda then Delzicol then Pentasa then Apriso

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 5: Lialda then Delzicol then Pentasa then Apriso

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Apriso 375 mg capsule x 3 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

Arm 6: Lialda then Delzicol then Apriso then Pentasa

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug)

Arm 6: Lialda then Delzicol then Apriso then Pentasa

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug)

Arm 6: Lialda then Delzicol then Apriso then Pentasa

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug)

Arm 6: Lialda then Delzicol then Apriso then Pentasa

Experimental
  1. Lialda 1200 mg tablet x 1 with 240 mL water, single dose.
  2. Washout period of 10 days.
  3. Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.
  4. Washout period of 10 days.
  5. Apriso 375 mg capsule x 3 with 240 mL water, single dose.
  6. Washout period of 10 days.
  7. Pentasa 500 mg capsule x 2 with 240 mL water, single dose.

干预措施: Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose (Drug)

结局指标

主要结局

The AUC of Mesalamine in Plasma

时间窗: 0 hours pre-dose and up to 96 hours post-dose

The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM\*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.

The AUC of Metabolite (N-acetyl-mesalamine) in Plasma

时间窗: 0 hours pre-dose and up to 96 hours post-dose

The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of N-acetyl-mesalamine per liter of plasma (nM) multiplied by time in hours (nM\*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.

次要结局

  • The AUC of Mesalamine in Distal Jejunum(0 hours pre-dose and up to 7 hours post-dose)
  • The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum(0 hours pre-dose and up to 7 hours post-dose)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Duxin Sun

Professor

University of Michigan

研究点 (1)

Loading locations...

相似试验

已完成
1 期
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.Asthma
NCT01494610GlaxoSmithKline60
已完成
4 期
Conversion From Brand to Generic Tacrolimus in High Risk Transplant RecipientsComplication of Transplant
NCT02014103University of Cincinnati71
已完成
1 期
TA-65 Pharmacokinetic StudyHealthy
NCT02731807NYU Langone Health8
已完成
1 期
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female SubjectsUlcerative Colitis
NCT03327558Bausch Health Americas, Inc.60
已完成
1 期
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of ChildrenPreoperative Sedation
NCT04200235Jiangsu HengRui Medicine Co., Ltd.48