Bioequivalence study of GLICLAVITE 60mg tablet of Vitabiotics Pharmed Co., IRA

Not Applicable

• Conditions: Diabetes.; Long term (current) use of oral hypoglycemic drugs; Z79. 84

• Registration Number: IRCT20190706044111N33
• Lead Sponsor: Vitabiotix Pharmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Aged between 18 - 50 years
Body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination
Understand the procedures and give written informed consent

Exclusion Criteria

Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment
Subject had a history of drug or alcohol abuse
Subject who smokes more than 10 cigarettes per day
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of gliclazide. Timepoint: at 0 (before dosing), 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 24.0, 48.0 & 72.0 hr. after dosing. Method of measurement: Using High Performance Liquid Chromatography wit UV detector (HPLC/UV).