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

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Status and phase: Completed; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: ATB-101, ATB-1011, ATB-1012

Study type: Interventional

Funder types: Industry

Identifiers

NCT05017987

ATB-101-002

Details and patient eligibility

About

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

Full 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

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sequence A=Reference-Test

Active Comparator group

Description:

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

Treatment:

Drug: ATB-101, ATB-1011, ATB-1012

Sequence B=Test-Reference

Active Comparator group

Description:

First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose

Treatment:

Drug: ATB-101, ATB-1011, ATB-1012