An open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 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 Pharmacokinetic 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 dose, crossover, oral bioequivalence study of Sitagliptin 50 mg &
Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and
metformin HCl (extended release) tablets 50 mg/500 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions.
OBJECTIVES:
Primary objective:
To compare the rate and extent of absorption of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience
Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions.
Secondary objective:
To monitor the safety and tolerability of the study subjects after administration of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets
in healthy, adult, human subjects under fed condition.
Number of subjects: Thirty-two (32) subjects
Duration of clinical study: 12 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •Body mass index in the range of 18.5 – 30.0 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 Diabetes mellitus type 1, Diabetic ketoacidosis including history of diabetic coma and precoma, acute or chronic metabolic acidosis, and Severe hepatic dysfunction (lack of experience of administration; in order to provide adequate glycaemic control, such patients should be treated with insulin)
- •Subjects on haemodialysis (lack of experience of administration), Acute and chronic disease which may cause tissue hypoxia (cardiac or respiratory failure, acute and sub-acute myocardial infarction, shock),
- •History of severe infection or major surgery in the past 6 months.
结局指标
主要结局
To evaluate Pharmacokinetic parameters: Cmax, AUC0-t and AUC0-∞
时间窗: From Day 01 to Day 12
次要结局
- To evaluate Pharmacokinetic parameters: Tmax, AUC_%Extrap_obs, λz and t1/2(From Day 01 to Day 12)
研究者
Dr Ankita Das
ICBio Clinical Research Private limited