An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period,Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended ReleaseTablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD(Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets(Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human MaleSubjects Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide
研究概览
简要总结
Servier India Private Limited has developed a fixed dose combination tablet containing gliclazide 60 mg with metformin 500 mg ( both extended release) as a bi-layered tablet. Similar product is approved in India manufactured and marketed by IPCA Laboratories.
The proposed project is An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended Release Tablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets (Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human Male Subjects Under Fasting Conditions.
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
- Male
入选标准
- •Healthy male human adult subjects (of 18 to 45 years of age (both inclusive) and weight of at least 50 kg.
- •Capable and willing to give informed written consent and to adhere to the study requirements.
- •Body Mass Index (BMI) between 18.50 30.00 Kg/m
- •Healthy individuals as evaluated by personal history, medical history and general clinical examination.
- •Absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history or physical examination judged by investigator.
- •Normal biochemical, haematological and urinary parameters or with abnormality considered to be clinically not significant and performed within 21 days prior to dosing of first period of the study.
- •Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis.
- •Non-smoker (for at least 6 months prior to first drug administration).
排除标准
- •History of any medical disorder that is of significance in the invesigators opinion.
- •Recent history of urinary retention, severe gastro-intestinal condition (including toxic mega colon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia.
- •History of any major surgical procedure in the past 3 months.
- •History of diabetes mellitus, tuberculosis and systemic hypertension.
- •History of any medication for treatment of joint pain, inflammation, stone in kidney or urinary tract prior to one month of screening day History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, metabolic, psychiatric or hematological illnesses, judged to be clinically significant.
- •Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.
- •History of dysphasia.
- •History or presence of cancer.
- •Difficulty in donating blood.
结局指标
主要结局
To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide
时间窗: 17 days
and Metformin Extended Release Tablets 60 mg / 500 mg tablets manufactured by Servier
时间窗: 17 days
India Private Limited (Test Product) and Glycinorm M OD (Gliclazide Modified Release
时间窗: 17 days
and Metformin Extended Release Tablets 60 mg / 500mg) tablets manufactured by IPCA
时间窗: 17 days
Laboratories, India in healthy, adult, human male subjects under fasting conditions
时间窗: 17 days
次要结局
- To monitor the safety and tolerability of a single dose administered in healthy,adult, human male subjects under fasting conditions.(Day 1 to Day 17)