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

Phase 1

Completed

• Conditions: Healthy Adult Volunteers
• Interventions: Drug: ATB-101, ATB-1011, ATB-1012

• Registration Number: NCT05017987
• Lead Sponsor: Autotelicbio

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

Study Timeline

• Study Start: 2021-06-19
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A=Reference-Test	ATB-101, ATB-1011, ATB-1012	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
Sequence B=Test-Reference	ATB-101, ATB-1011, ATB-1012	First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose

Primary Outcome Measures

Name	Time	Method
Cmax of Olmesartan	Day1(first stage), Day8(scond stage)	Maximum concentration of drug in plasma
AUCt of Olmesartan	Day1(first stage), Day8(scond stage)	Area under the concentration-time curve
AUCt of Dapagliflozin	Day1(first stage), Day8(scond stage)	Area under the concentration-time curve
Cmax of Dapagliflozin	Day1(first stage), Day8(scond stage)	Maximum concentration of drug in plasma

Secondary Outcome Measures

Name	Time	Method
AUC∞ of Dapagliflozin	Day1(first stage), Day8(scond stage)	Area under the plasma drug concentration-time curve from time 0 to infinity
Tmax of Dapagliflozin	Day1(first stage), Day8(scond stage)	Time to maximum plasma concentration
CL/F of Dapagliflozin	Day1(first stage), Day8(scond stage)	Apparent total clearance of the drug from plasma after oral administration
Tmax of Olmesartan	Day1(first stage), Day8(scond stage)	Time to maximum plasma concentration
Vd/F of Dapagliflozin	Day1(first stage), Day8(scond stage)	Apparent volume of distribution after non-intravenous administration
AUC∞ of Olmesartan	Day1(first stage), Day8(scond stage)	Area under the plasma drug concentration-time curve from time 0 to infinity
CL/F of Olmesartan	Day1(first stage), Day8(scond stage)	Apparent total clearance of the drug from plasma after oral administration
T1/2 of Dapagliflozin	Day1(first stage), Day8(scond stage)	Terminal elimination half-life
T1/2 of Olmesartan	Day1(first stage), Day8(scond stage)	Terminal elimination half-life
Vd/F of Olmesartan	Day1(first stage), Day8(scond stage)	Apparent volume of distribution after non-intravenous administration

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Seoul, Gwanak-gu, Korea, Republic of