An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private Ltd., in comparison with Janumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
研究概览
简要总结
STUDY TITLE:
An open label, balanced,randomized, two-treatment, two-period, two-sequence, single oral dose,crossover, bioequivalence study of Sitagliptin 100 mg &Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience PrivateLtd., in comparison withJanumet XR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl(extended release) tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fedconditions
OBJECTIVES:
Primaryobjective:
To compare the rate and extent ofabsorption of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg(extended release) Tablets of SunGlow Lifescience Private Ltd., with that of JanumetXR 100 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extended release)tablets 100 mg/1,000 mg} of Merck Sharp & Dohme Corp inhealthy, adult, human subjects under fed condition.
Secondaryobjective:
Tomonitor the safety and tolerability of the study subjects after administrationof Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release)Tablets in healthy, adult, human subjectsunder fed condition.
Number of subjects: Thirty two (32)
Duration of clinical study: 11 days
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- •Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
- •Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
排除标准
- •Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs.
- •History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
- •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.
结局指标
主要结局
To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-∞
时间窗: from Day 01 to Day 11
次要结局
- To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 11)