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COMPLETED
NCT07691203
PHASE1

Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets

Sponsor: Humanis Saglık Anonim Sirketi

View on ClinicalTrials.gov

Summary

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fed condition.

Official title: An Open Label, Randomized, Two-period, Two Treatment, Two-sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study to Compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR (Empagliflozin, Linagliptin, and Metformin Hydrochloride Extended-release Tablets) 25 mg/5 mg/1000 mg in Fed Condition.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-03-07

Completion Date

2026-07-01

Last Updated

2026-07-08

Healthy Volunteers

Yes

Interventions

DRUG

Empagliflozin/Linagliptin/Metformin HCl Extended Release Tablet

1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg

DRUG

Trijardy® XR Tablets

1 extended Release tablet of Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg

Locations (1)

Cliantha Research Limited

Ahmedabad, Sarkhej, India