NCT02306772已完成1 期
An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Tablet release
研究概览
简要总结
This is a Phase I, open-label, single-site trial to evaluate the drug release, using Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9] subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive formulation B and the second 9 subjects will receive formulation A. The subjects will be treated once with the radio-labelled study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy subjects, male or non-pregnant, non-lactating females, between 18 and 55 years old. Females of child bearing potential must have a negative serum pregnancy test prior to the intake of study drug, and must use a hormonal (oral, implantable or injectable) or a double barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
- •Ability of subject to participate fully in all aspects of this clinical trial.
- •Voluntarily signed informed consent must be obtained and documented.
排除标准
- •Participating in a clinical study involving investigational drugs or dosage forms within the previous 2 months.
- •History of alcohol or drug abuse.
- •Radiation exposure from clinical trials, including that from the present study and from diagnostic X-ray but excluding background radiation, exceeds 5 mSV in the last 12 months or 10 mSv in the last 5 years. No subject whose occupational exposure is monitored will participate in the study.
- •Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
- •Clinically significant abnormal biochemistry, haematology or urine analyses:
- •White blood count < 3 x 109/L and > 8 x 109/L
- •Lymphocyte count < 0.85 x 109/L
- •Haemoglobin < 110 g/L
- •Platelet count < 125 x 109/L or > 600 x 109/L
- •Alanine-Aminotransferase (ALT) or Aspartate-Aminotransferase (AST) > 2x upper limit normal
- •Alkaline Phosphatase > 2x upper limit normal
- •Serum Creatinine > upper limit normal
- •History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
- •History of cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
- •History of adverse reaction or allergy to Mesalazine or other salicylates.
- •Acute diarrhoea or constipation in the 14 days before the predicted first study day. If screening occurs >14 days before first study day, this criterion is to be determined on the first study day. Diarrhoea will be defined as the passage of liquid faeces and/or qa stool frequency of > 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day.
- •Donation of blood within the previous three months.
- •Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-Antibody (Human Immunodeficiency Virus) results.
- •Over-the-counter (OTC) and prescription medication (including laxatives, vitamin-pills and natural herbal remedies) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicyl-acid is permitted.
- •Failure to satisfy the Principle Investigator to participate for any other reason.
研究组 & 干预措施
Formulation B
Experimental
TP05 Coating B
干预措施: TP05 Coating B (Drug)
Formulation A
Experimental
TP05 Coating A
干预措施: TP05 Coating A (Drug)
结局指标
主要结局
Tablet release
时间窗: 3 days
次要结局
- Maximal Plasma Concentration (Cmax)(3 days)
- Elimination rate constant (k)(3 days)
- Area under the concentration-time curve(3 days)
- Lag time (t-lag)(3 days)
- Time to reach Cmax (Tmax)(3 days)
研究者
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