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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- AUCt of Olmesartan
Study Overview
Brief 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
- Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
- Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan
Safety evaluation
- Adverse reactions (but only in case of TEAE)
- Concomitant drugs
- Vital signs
- Laboratory test
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Those who are over 19 years old at the screening visit
- •Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
- •Those who determined as suitable study subjects by the principal investigator
- •A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial
Exclusion Criteria
- •Those who have a clinically significant disease or have a history of such disease
- •Those who have a history of gastrointestinal surgery
- •Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs
- •Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
- •Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date
Arms & Interventions
Sequence A=Reference-Test
T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012
First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose
Intervention: ATB-101, ATB-1011, ATB-1012 (Drug)
Sequence B=Test-Reference
First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose
Intervention: ATB-101, ATB-1011, ATB-1012 (Drug)
Outcomes
Primary Outcomes
AUCt of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Olmesartan
Time Frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
AUCt of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Dapagliflozin
Time Frame: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
Secondary Outcomes
- AUC∞ of Dapagliflozin(Day1(first stage), Day8(scond stage))
- Tmax of Dapagliflozin(Day1(first stage), Day8(scond stage))
- CL/F of Dapagliflozin(Day1(first stage), Day8(scond stage))
- Tmax of Olmesartan(Day1(first stage), Day8(scond stage))
- Vd/F of Dapagliflozin(Day1(first stage), Day8(scond stage))
- AUC∞ of Olmesartan(Day1(first stage), Day8(scond stage))
- CL/F of Olmesartan(Day1(first stage), Day8(scond stage))
- T1/2 of Dapagliflozin(Day1(first stage), Day8(scond stage))
- T1/2 of Olmesartan(Day1(first stage), Day8(scond stage))
- Vd/F of Olmesartan(Day1(first stage), Day8(scond stage))