Randomized, Crossover Trial
- Registration Number
- CTRI/2023/02/049496
- Lead Sponsor
- Servier India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
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/m2.
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.
Have a normal 12 lead ECG or with an abnormality considered to be clinically not
significant.
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).
Ability to fast for at least 14.00 hours and consume standard meals.
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide <br/ ><br>and Metformin Extended Release Tablets 60 mg / 500 mg tablets manufactured by Servier <br/ ><br>India Private Limited (Test Product) and Glycinorm M OD (Gliclazide Modified Release <br/ ><br>and Metformin Extended Release Tablets 60 mg / 500mg) tablets manufactured by IPCA <br/ ><br>Laboratories, India in healthy, adult, human male subjects under fasting conditionsTimepoint: 17 days
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of a single dose administered in healthy,adult, human male subjects under fasting conditions.Timepoint: Day 1 to Day 17