NCT04856969

Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Autotelicbio · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.

Detailed description

* Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state. * Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	Olmesartan	First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
DRUG	Dapagliflozin	First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration

Timeline

• Start date: 2021-03-30
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2021-04-23
• Last updated: 2021-09-05

Locations

1 site across 1 country: South Korea