An open label balanced randomized two treatment two period two sequence single oral dose crossover bioequivalence study of Sitagliptin 50 mg Metformin Hydrochloride 1000 mg extended release Tablets of SunGlow Lifescience Private Ltd in comparison with Janumet XR 50 mg 1000 mg tablets Sitagliptin and metformin HCl extended release tablets 50 mg 1000 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
- 招募中
- 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 50 mg &Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlowLifescience Private Ltd.,in comparison with Janumet XR 50 mg/1000 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50mg/1000 mg} of Merck Sharp & Dohme Corp inhealthy, adult, human subjects under fed conditions.
OBJECTIVES:
Primaryobjective:
To compare the rate and extent ofabsorption of Sitagliptin 50 mg & Metformin Hydrochloride 1000 mg (extendedrelease) Tablets of SunGlow Lifescience Private Ltd., with that of JanumetXR 50 mg/ 1000 mg tablets {Sitagliptin and metformin HCl (extendedrelease) tablets 50 mg/1000 mg} of Merck Sharp & Dohme Corp inhealthy, adult, human subjects under fedcondition.
Secondaryobjective:
Tomonitor the safety and tolerability of the study subjects after administrationof Sitagliptin 50 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
- •1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in 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 45 years both inclusive of age 4 Body mass index in the range of 18 30 kg/m2 both inclusive 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI/CI/Physician.
排除标准
- •1 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs 2 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past 3 History of severe infection or major surgery in the past 6 months 4 History of Minor surgery or fracture within the past 3 months 5 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)