Clinical trial NCT05017987: Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Autotelicbio
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open, Randomization, single oral administration, 2 Intervention group, crossover design
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: AUCt of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: Cmax of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: AUCt of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
measure: Cmax of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
Secondary outcomes:
measure: AUC∞ of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: Tmax of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: T1/2 of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: CL/F of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: Vd/F of Olmesartan
timeFrame: Day1(first stage), Day8(scond stage)
measure: AUC∞ of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
measure: Tmax of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
measure: T1/2 of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
measure: CL/F of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
measure: Vd/F of Dapagliflozin
timeFrame: Day1(first stage), Day8(scond stage)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Gwanak-gu
Study officials:
affiliation: H + Yangji Hospital
name: Jaewoo Kim
role: PRINCIPAL_INVESTIGATOR
References: