NCT07039890

To Compare and Evaluate the Oral Bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg Filmcoated Tablets With That of Glyxambi 10 mg/ 5 mg Film-coated Tablets in Healthy, Adult, Human Subjects Under Fasting Conditions.

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

To compare and evaluate the oral bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg film-coated tablets with that of Glyxambi 10 mg/ 5 mg film-coated tablets in healthy, adult, human subjects under fasting conditions.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Empagliflozin + Linagliptin filmcoated tablets	Empagliflozin + Linagliptin 10 mg/5 mg filmcoated tablets
DRUG	Glyxambi film-coated tablets	Glyxambi 10 mg/5 mg film-coated tablets

Timeline

• Start date: 2025-03-08
• Primary completion: 2025-05-14
• Completion: 2025-06-05
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: India