NCT04972539

Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults

A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

Detailed description

This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	AJU-A51 Tab.	Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
DRUG	A51R1 Tab. and A51R2 Tab.	Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-11-30
• Completion: 2021-03-09
• First posted: 2021-07-22
• Last updated: 2021-07-22

Locations

1 site across 1 country: South Korea