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.
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|ClinicalTrials.gov Identifier: NCT02395237|
Recruitment Status : Withdrawn
First Posted : March 23, 2015
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: : Amaryl® M IR 2/1000||Phase 1|
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.
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)
Glimepiride and metformin: Cmax and AUClast
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Amaryl® M IR 2/1000 (manufactured in India)
Investigational products :Reference formulation Trade Name: Amaryl® M IR 2/1000 (manufactured in India) Dosage Form: Film coated tablet 1x1 Active Substance: Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Goa, India
Drug: : Amaryl® M IR 2/1000
Experimental: Amaryl® M IR 2/1000 (manufactured in Turkey)
Dosage form: Film coated tablet 1x1 Active substance : Glimepiride/metformine HCl 2 mg/1000 mg Manufacturer: Zentiva TR, Lüleburgaz
Drug: : Amaryl® M IR 2/1000
- Cmax [ Time Frame: 0-72 ]
- AUC0-t [ Time Frame: 0-72 ]
- AUC0-inf [ Time Frame: 0-72 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395237
|Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit|
|Amman, Jordan, 00962|