NCT01058824已完成1 期
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule 500 Mg Formulations, In Healthy Volunteers Using Formulations (Frademicina®) Manufactured By Pfizer Laboratories Ltd
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUC [0-t]Area under the curve of concentration vs. time, from time 0 (zero) up to the time of the last observed concentration above the limit of quantification, calculated by the trapezium rules.
研究概览
简要总结
To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The formulations' comparative bioavailability after oral administration will be assessed based on the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured by a proper and validated analytical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women who are not pregnant nor nursing.
- •Age between 18 and 50 years-old.
- •Body mass index ≥ 19 and ≤ 28,
- •Good health conditions or with no significant diseases, under judgement of the legally qualified professional, according to the rules defined in the Protocol, and based on the following assessments: clinical history, pressure and pulse measurements, physical and psychological examination, ECG and complementary laboratorial tests.
- •Ability to understand the nature and the objective of the trial, including the risks and adverse effects and, agreeing to cooperate with the investigator and to act according to the requirements of the whole assay, which will be confirmed through the signature of the Free Informed Consent.
排除标准
- •Known hypersensitivity to the study drug (lincomycin hydrocloride) or to compounds chemically related.
- •History or presence of hepatic, gastrointestinal diseases or other conditions that may interfere with the absorption, distribution, excretion or metabolism process of the drug.
- •History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematological or psychiatric condition; of hypo or hypertension from any etiology that require pharmacological treatment; history or had myocardial infarction, angina and/or cardiac insufficiency.
- •Electrocardiographic findings non-recommended for the enrollment in the trial, by investigator's criteria.
- •Results of the laboratory tests are out of the normal range, according to the standards of this protocol, unless they are considered clinically irrelevant by the investigator.
- •He/She is a smoker.
- •Drinks more than 05 cups of coffee or tea per day.
- •History of alcohol or drug abuse.
- •Use of regular medication within 02 weeks prior to the beginning of the treatment and to the assessment date; or use of any medication within a week, except for contraceptive medications.
- •Hospitalization for any reason within 08 weeks prior to the beginning of the first treatment period of this trial and to the assessment date.
- •Treatment within 03 months prior to the trial with any drug with known toxic potential on primary organs.
- •Enrollment to any experimental trial or use of any experimental drug within 06 months prior to the beginning of this trial and to the assessment date.
- •Donation or loss of 450 mL or more of blood within 03 months that precede the trial or donation higher than 1500 mL within the 12 months between the beginning of the clinical trial and the assessment date.
- •Consumption of inducing and/or inhibiting enzymatic drugs (CYP450 - hepatic), toxic to organ or with long half-life period, within 04 weeks prior to the beginning of the trial.
- •Consumption of alcohol within 48 hours preceding the enrollment to the trial and during the clinical trial.
- •Consumption of food and beverages that contained grapefruit up to 07 days prior to each trial period.
研究组 & 干预措施
Lincomycin - Active Comparative - Hard Gelatin Capsule
Active Comparator
干预措施: Lincomycin (Drug)
Lincomycin - Study Drug - Hard Gelatin Capsule
Experimental
干预措施: Lincomycin (Drug)
结局指标
主要结局
AUC [0-t]Area under the curve of concentration vs. time, from time 0 (zero) up to the time of the last observed concentration above the limit of quantification, calculated by the trapezium rules.
时间窗: 1 week
Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time;
时间窗: 1 week
次要结局
- quantification.(1 week)
- AUC [0-¥]Area under the curve of drug concentration versus time, from time 0 (zero) extrapolated to the infinite, calculated as AUC [0-¥] = AUC [0-t] + Ct/Ke, in which Ct is the last concentration determined above the limit of(1 week)
- Ke Terminal First Order Elimination Constant, estimated by the angular coefficient of the linear regression, calculated by the Least Square Method, from the natural logarithms of concentration vs. time to the last four values of concentration (or at(1 week)
- least three) above the limit of quantification.(1 week)
- T½ Half-life time, calculated as ln (2) / Ke.(1 week)
- Adverse events and vital signs.(1 week)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy VolunteersHealthyNCT01692834NeuroVive Pharmaceutical AB65
已完成
1 期
A Relative Bioavailability Study Between Two Formulations Of Sildenafil CitrateErectile DysfunctionNCT00904748Pfizer's Upjohn has merged with Mylan to form Viatris Inc.47
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.AsthmaNCT01494610GlaxoSmithKline60
已完成
1 期
A Study to Compare Two Forms of LY2608204 in Healthy PeopleHealthy VolunteersNCT01313286Eli Lilly and Company16
已完成
1 期
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without FoodHealthyNCT05155306Boehringer Ingelheim24