NCT06932159

Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Two Period, Two Way Crossover Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, balanced, randomized, single dose, two treatment, two sequence, two period, two way crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Empagliflozin + Linagliptin film-coated tablets	1 tablet of Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets
DRUG	Glyxambi film-coated tablets	1 tablet of Glyxambi 25 mg/ 5 mg film-coated tablets

Timeline

• Start date: 2024-12-23
• Primary completion: 2025-03-07
• Completion: 2025-04-08
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: India