NCT05017987

Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012

A Phase I Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Autotelicbio · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers

Detailed description

Pharmacokinetic endpoints 1. Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan 2. Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan Safety evaluation 1. Adverse reactions (but only in case of TEAE) 2. Concomitant drugs 3. Vital signs 4. Laboratory test

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	ATB-101, ATB-1011, ATB-1012	1. Test drug \- Code name: ATB-101 2. Control drug1 * Code name: ATB-1011 * Active ingredient: Olmesartan 3. Control drug2 * Code name: ATB-1012 * Active ingredient: Dapagliflozin

Timeline

• Start date: 2021-06-19
• Primary completion: 2021-07-12
• Completion: 2021-07-12
• First posted: 2021-08-24
• Last updated: 2024-01-31

Locations

1 site across 1 country: South Korea