NCT05956522

Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects

Single-center, Open, Randomized, Single-dose, Crossover Bioequivalence Study Evaluating the Use of the Subject Formulation, Empagliflozin And Linagliptin Tablets, Versus the Reference Formulation, Empagliflozin And Linagliptin Tablets (Glyxambi®), in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate the pharmacokinetics of the test and the reference preparation Empagliflozin And Linagliptin Tablets in healthy adult subjects by single oral administration in fasting/postprandial state, and to evaluate the bioequivalence of the two oral preparations in fasting/postprandial state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test Empagliflozin And Linagliptin Tablets	specification: 25 mg/5 mg, manufacturer: Qilu Pharmaceutical (Hainan) Co., Ltd
DRUG	Reference Empagliflozin And Linagliptin tablets	specification: 25 mg/5 mg, manufacturer: Boehringer Ingelheim International GmbH \& Co. KG

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-11-23
• Completion: 2023-01-13
• First posted: 2023-07-21
• Last updated: 2023-07-21

Locations

1 site across 1 country: China