Bioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) vs. JARDIANCE® (25 mg Tablets), in Healthy Research Subjects, Under Fasting Conditions

Sponsor: ADIUM
Study ID: NCT07479108
Status: Completed

Conditions

Bioequivalance

Eligibility Criteria

Sex: ALL
Age: 18 Years - 55 Years
Healthy Volunteers: Not accepted

Interventions

Empagliflozin (Jardiance®) — DRUG
Reference. empagliflozin 25 mg tablet
Empagliflozin (oral) — DRUG
Test. empagliflozin 25 mg tablet

Study Details

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

Key Dates

Start date: Nov 29, 2024
Status verified: Mar 2026
Primary completion: Dec 11, 2024
Completion: Dec 11, 2024

Study Design

Enrollment: 32 participants (actual)
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Arms

Active Comparator: Jardiance 25 mg tablet
Reference
Experimental: Empagliflozin 25 mg tablet
Test.

Primary Outcome Measure

Bioequivalence based on the pharmacokinetic parameter: Cmax [ Time Frame: Through 72 Hours Post Dose ]