CompletedPhase 1

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

India40 participantsStarted 2026-02-06

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam
. Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak Plasma Concentration (Cmax)

Timeframe: 72.00 hours

Area Under the Curve from time zero to time of last measurable concentration (AUC0-t)

Timeframe: 72.00 hour

Trial details

NCT IDNCT07691177

SponsorHumanis Saglık Anonim Sirketi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-27

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