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

NCT ID: NCT05017987

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-19
• Study Completion Date: 2021-07-12

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

Conditions

Healthy Adult Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ATB-101, ATB-1011, ATB-1012

Intervention Type: DRUG

1. Test drug

• Code name: ATB-101

2. Control drug1

• Code name: ATB-1011
• Active ingredient: Olmesartan

3. Control drug2

• Code name: ATB-1012
• Active ingredient: Dapagliflozin

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

Group Type: ACTIVE_COMPARATOR

ATB-101, ATB-1011, ATB-1012

Intervention Type: DRUG

1. Test drug

• Code name: ATB-101

2. Control drug1

• Code name: ATB-1011
• Active ingredient: Olmesartan

3. Control drug2

• Code name: ATB-1012
• Active ingredient: Dapagliflozin

Interventions

ATB-101, ATB-1011, ATB-1012

1. Test drug

• Code name: ATB-101

2. Control drug1

• Code name: ATB-1011
• Active ingredient: Olmesartan

3. Control drug2

• Code name: ATB-1012
• Active ingredient: Dapagliflozin

Intervention Type: DRUG

Other Intervention Names

ATB-1011 brand name: Olmetec; ATB-1012 brand name: Forxiga

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Autotelicbio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaewoo Kim

Role: PRINCIPAL_INVESTIGATOR

H + Yangji Hospital

Locations

H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea

Countries

South Korea

Other Identifiers

ATB-101-002

Identifier Type: -

Identifier Source: org_study_id