NCT05077462

A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52H in Healthy Volunteers

An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AJU-C52H Compared to Coadministration of C52R1M With C52R2 in Healthy Adult Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and pharmacokinetic characteristics of AJU-C52H in healthy adults

Detailed description

This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1M with C52R2 and administration of AJU-C52H. This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	C52R1M Tab. and C52R2 Tab.	Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
DRUG	AJU-C52H	Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet

Timeline

• Start date: 2021-09-17
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2021-10-14
• Last updated: 2021-10-14

Locations

1 site across 1 country: South Korea