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

NCT05017987 | Completed Phase 1

• 1 other identifier: ATB-101-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (4)

• AUCt of Olmesartan

  Area under the concentration-time curve

  Day1(first stage), Day8(scond stage)

• Cmax of Olmesartan

  Maximum concentration of drug in plasma

  Day1(first stage), Day8(scond stage)

• AUCt of Dapagliflozin

  Area under the concentration-time curve

  Day1(first stage), Day8(scond stage)

• Cmax of Dapagliflozin

  Maximum concentration of drug in plasma

  Day1(first stage), Day8(scond stage)

Secondary Outcomes (10)

• AUC∞ of Olmesartan

  Day1(first stage), Day8(scond stage)

• Tmax of Olmesartan

  Day1(first stage), Day8(scond stage)

• T1/2 of Olmesartan

  Day1(first stage), Day8(scond stage)

• CL/F of Olmesartan

  Day1(first stage), Day8(scond stage)

• Vd/F of Olmesartan

  Day1(first stage), Day8(scond stage)

Study Arms (2)

Sequence A=Reference-Test

ACTIVE COMPARATOR

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

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

Sequence B=Test-Reference

ACTIVE COMPARATOR

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

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

Interventions

ATB-101, ATB-1011, ATB-1012 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

Also known as: ATB-1011 brand name: Olmetec, ATB-1012 brand name: Forxiga

Sequence A=Reference-Test; Sequence B=Test-Reference

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Autotelicbio: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

Study Officials

• Jaewoo Kim

  H + Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open, Randomization, single oral administration, 2 Intervention group, crossover design

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: June 19, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)