NCT02395237

COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pharmaceutical Research Unit, Jordan · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

Detailed description

An open-label, randomized, two-treatment crossover bioequivalence study comparing two batches of the same fixed dose combinations Amaryl® M IR 2/1000 (glimepiride/metformin hydrochloride immediate release combination tablet) in fed conditions in healthy male and/or female subjects. Primary Objective To assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey. Secondary Objective(s) To assess the safety (including hypoglycemic events) of the two FDC (Amaryl® M IR 2/1000) tablets. Up to 50 healthy subjects are to be enrolled to have 46 subjects available for the final pharmacokinetic evaluation. Study treatment: In each period A single dose of glimepiride/metformin HCl 2mg/1000 mg FDC (manufactured in India) Or single dose of glimepiride/metformin HCl 2mg/1000 mg FDC (manufactured in Turkey) will be administered after breakfast. PRIMARY AND SECONDARY ENDPOINT(S) Primary Endpoint: Glimepiride and metformin: Cmax and AUClast Secondary Endpoint(s): Glimepiride and metformin: AUC0-inf, tlag, tmax and t1/2z Safety DURATION OF STUDY (per patient) Screening : up to 15 days Treatments periods: 4 days each including treatment day Wash-out period: 4 to 7 days Follow-up: 4 to 7 days Total study duration: 37 days

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	: Amaryl® M IR 2/1000

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2015-03-23
• Last updated: 2020-09-18

Locations

1 site across 1 country: Jordan