NCT07479108

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

Bioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) From Asofarma de México S.A. de C.V. vs. JARDIANCE® (25 mg Tablets) From Boehringer Ingelheim Pharmaceuticals Inc., in Healthy Research Subjects, Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: ADIUM · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 7-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 25 mg empagliflozin tablet formulations in thirty-two (32) healthy Mexican adult volunteers aged 18 to 55 years.

Conditions

• Bioequivalance

Interventions

Type	Name	Description
DRUG	Empagliflozin (Jardiance®)	Reference. empagliflozin 25 mg tablet
DRUG	Empagliflozin (oral)	Test. empagliflozin 25 mg tablet

Timeline

• Start date: 2024-11-29
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Mexico