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

Healthy Adult Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017987
• Other study ID #: ATB-101-002
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: January 2024
• Source: Autotelicbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• ATB-101, ATB-1011, ATB-1012
Test drug - Code name: ATB-101 Control drug1 Code name: ATB-1011 Active ingredient: Olmesartan Control drug2 Code name: ATB-1012 Active ingredient: Dapagliflozin

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul	Gwanak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Autotelicbio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of Olmesartan	Area under the concentration-time curve	Day1(first stage), Day8(scond stage)
Primary	Cmax of Olmesartan	Maximum concentration of drug in plasma	Day1(first stage), Day8(scond stage)
Primary	AUCt of Dapagliflozin	Area under the concentration-time curve	Day1(first stage), Day8(scond stage)
Primary	Cmax of Dapagliflozin	Maximum concentration of drug in plasma	Day1(first stage), Day8(scond stage)
Secondary	AUC8 of Olmesartan	Area under the plasma drug concentration-time curve from time 0 to infinity	Day1(first stage), Day8(scond stage)
Secondary	Tmax of Olmesartan	Time to maximum plasma concentration	Day1(first stage), Day8(scond stage)
Secondary	T1/2 of Olmesartan	Terminal elimination half-life	Day1(first stage), Day8(scond stage)
Secondary	CL/F of Olmesartan	Apparent total clearance of the drug from plasma after oral administration	Day1(first stage), Day8(scond stage)
Secondary	Vd/F of Olmesartan	Apparent volume of distribution after non-intravenous administration	Day1(first stage), Day8(scond stage)
Secondary	AUC8 of Dapagliflozin	Area under the plasma drug concentration-time curve from time 0 to infinity	Day1(first stage), Day8(scond stage)
Secondary	Tmax of Dapagliflozin	Time to maximum plasma concentration	Day1(first stage), Day8(scond stage)
Secondary	T1/2 of Dapagliflozin	Terminal elimination half-life	Day1(first stage), Day8(scond stage)
Secondary	CL/F of Dapagliflozin	Apparent total clearance of the drug from plasma after oral administration	Day1(first stage), Day8(scond stage)
Secondary	Vd/F of Dapagliflozin	Apparent volume of distribution after non-intravenous administration	Day1(first stage), Day8(scond stage)