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COMPLETED
NCT07691177
PHASE1

Bioequivalence Study to Compare Imeglimin HCl 500 mg Film Coated Tablets Versus Twymeeg Tablets 500 mg

Sponsor: Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of Imeglimin HCl 500 mg Film Coated Tablets of Humanis Sağlık A.Ş., Ç.O.S.B. Karaağaç Mahallesi Fatih Bulvarı No:32 Kapaklı/TEKİRDAĞ and Twymeeg Tablets 500 mg of Sumitomo Pharma Co., Ltd. 2-6-8, Dosho-machi, Chuo-Ward, Osaka City, in Healthy, Adult, Human Participants Under Fasting Condition.

Official title: An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Oral Bioequivalence Study of Imeglimin HCl 500 mg Film Coated Tablets and Twymeeg Tablets 500 mg in Healthy, Adult, Human Participants Under Fasting Condition.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-06

Completion Date

2026-05-13

Last Updated

2026-07-08

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Imeglimin Hydrochloride Film Coated Tablet

1 tablet of 500 mg Imeglimin Hydrochloride

DRUG

TWYMEEG® Tablets

1 tablet of 500 mg Imeglimin Hydrochloride

Locations (1)

Veeda Clinical Research Ltd.

Gujrāt, Ahmedabad, India