An Open label, balanced, randomized, two-period, two-treatment, two-sequence, single oral dose, crossover, bioequivalence study on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To compare rate and extend of orally administered molecule to prove bioequivalence on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting conditions.
研究概览
简要总结
An Open label,balanced, randomized, two-period, two-treatment, two-sequence, single oraldose, crossover, bioequivalence study on RIFAIZO PE (Rifampicin150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) filmcoated tablets of Swiss Parenterals Ltd. with VORACTIV(Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg +Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fastingconditions.
Primaryobjective:
To compare rate and extend of orallyadministered molecule to prove bioequivalence on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg +Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV(Rifampicin 150mg + Isoniazide 75mg +Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of SandozLimited in healthy adult human subjects under fasting conditions.
Secondaryobjective:
To monitor and assesssafety and tolerability of the investigational products in healthy adult, humansubjects under fasting condition
32 subjects will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •2.Willing to be available for the entire study period and to comply with protocol requirements.
- •3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •4.Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
- •5.Normal haemoglobin between 13.8 to 17.2 grams per deciliter (g/dL) for men and 12.1 to 15.1 g/dL for female.
- •6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
- •7.With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no.
- •8.With a normal or clinically non-significant 12-lead ECG.
- •9.With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
排除标准
- •1.Haemoglobin level less than 13.5 grams per deciliter for men and 12 grams per deciliter for women. 2.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs. 3.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 4.Taking any iron preparation already at the time of enrolment. 5.History of severe infection or major surgery in the past 6 months. 6.History of Minor surgery or fracture within the past 3 months. 7.Significant history or current evidence of malignancy or chronic.
- •infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 8.Any major illness or hospitalized within 90 days prior to the first dosing.
结局指标
主要结局
To compare rate and extend of orally administered molecule to prove bioequivalence on RIFAIZO PE (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Swiss Parenterals Ltd. with VORACTIV (Rifampicin 150mg + Isoniazide 75mg + Pyrazinamide 400mg + Ethambutol 275mg) film coated tablets of Sandoz Limited in healthy adult human subjects under fasting conditions.
时间窗: from Day 1 to day 11
次要结局
- To monitor and assess safety and tolerability of the investigational products in healthy adult, human subjects under fasting condition.(from Day 1 to day 11)