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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Drug: ATB-101, ATB-1011, ATB-1012

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08779
      • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: ATB-101, ATB-1011, ATB-1012; Test drug- Code name: ATB-101; Control drug1Code name: ATB-1011Active ingredient: Olmesartan; Control drug2Code name: ATB-1012Active ingredient: Dapagliflozin; Other Names: ATB-1011 brand name: Olmetec; ATB-1012 brand name: Forxiga
Active Comparator: 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	Drug: ATB-101, ATB-1011, ATB-1012; Test drug- Code name: ATB-101; Control drug1Code name: ATB-1011Active ingredient: Olmesartan; Control drug2Code name: ATB-1012Active ingredient: Dapagliflozin; Other Names: ATB-1011 brand name: Olmetec; ATB-1012 brand name: Forxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Autotelicbio
• Investigators: Principal Investigator: Jaewoo Kim, H + Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2021
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan Medoxomil
• Other Study ID Numbers: ATB-101-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No