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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41840459

Enrollment

Registered

2010-09-17

Start date

2010-09-13

Completion date

Unknown

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

Five periods, single administration: one oral solution of 60 mg gliclazide, three different gliclazide MR 60 mg - metformin fixed tablet combinations and free combination (gliclazide MR 60 mg and metf

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Determination of the plasma gliclazide and metformin concentration-time data	—

Secondary

Measure	Time frame
1. Adverse events (at all visits) 2. Physical examination (at all visits) 3. 12-lead ECG (at ASSE visit and at the end-of-study visit) 4. Biochemistry and haematology (at ASSE visit, at D1 and at the end-of-study visit)	—

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026