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. - BA/BE Study

Servier India Private Limited0 个研究点目标入组 49 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•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
•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

发起方

Servier India Private Limited