A study to assess the release profiles from fixed combination tablets (gliclazide MR/metformin)

Phase 1

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN41840459
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-17
• Study Completion: 2010-11-30
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Healthy male volunteers between the ages of 18 - 40 years inclusive
2. Normal clinical examination

Exclusion Criteria

Clinically significant abnormality in laboratory screening, including haematology, blood biochemistry and urinalysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the plasma gliclazide and metformin concentration-time data

Secondary Outcome Measures

Name	Time	Method
1. Adverse events (at all visits)<br>2. Physical examination (at all visits)<br>3. 12-lead ECG (at ASSE visit and at the end-of-study visit)<br>4. Biochemistry and haematology (at ASSE visit, at D1 and at the end-of-study visit)