An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 (Contains 150 Mg Rifampicin And 75 Mg Isoniazid Per Tablet) To An Equivalent Dose Of Single Drug Reference Preparations Of Rifampicin And Isoniazid Following Oral Administration In Healthy Adults Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
研究概览
简要总结
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results;
- •Pregnant or nursing female;
- •History or active tuberculosis;
- •Participated in investigational drug studies within 3 months;
- •Used prescription or nonprescription drugs within 7 days or 5 half-lives.
研究组 & 干预措施
Test
RIN 150 contains 150 rifampicin and 75 mg isoniazid
干预措施: RIN 150 (Drug)
Reference
Individual references of rifampicin and isoniazid
干预措施: reference drugs (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
Cmax was reported for rifampicin and isoniazid.
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1)
- Plasma Decay Half-Life (t1/2)(0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1)