NCT04970940

The Drug-drug Interaction Study of AJU-A51R1 and AJU-A51R2

An Open-label, Multiple Dose, Crossover Study to Evaluate the Drug-drug Interaction Between AJU-A51R1 and AJU-A51R2 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers.

Detailed description

This study is to investigate drug-drug interaction between AJU-A51R1 and AJU-A51R2.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	Treatment A	AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days
DRUG	Treatment B	AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days
DRUG	Treatment C	AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days

Timeline

• Start date: 2020-07-02
• Primary completion: 2020-10-07
• Completion: 2020-12-31
• First posted: 2021-07-21
• Last updated: 2021-07-21

Locations

1 site across 1 country: South Korea