Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
- Sponsor
- Autotelicbio
- Study ID
- NCT04856969
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Adult Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Olmesartan — DRUGFirst stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
- Dapagliflozin — DRUGFirst stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
Study Details
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.
Key Dates
- Start date
- Mar 30, 2021
- Status verified
- Aug 2021
- Primary completion
- May 4, 2021
- Completion
- May 4, 2021
Study Design
- Enrollment
- 38 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm AATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days
- Active Comparator: Arm BATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days
Primary Outcome Measure
ATB-1011 AUCτ,ss [ Time Frame: 5days, 10days ]