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

NCT07691177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-08

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2026-03-27
Completion
2026-05-13

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691177 on ClinicalTrials.gov