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Completed

NCT Number: NCT05017987

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

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

Completed

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

About this study

Pharmacokinetic endpoints

  • Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
  • Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan

Safety evaluation

  • Adverse reactions (but only in case of TEAE)
  • Concomitant drugs
  • Vital signs
  • Laboratory test

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATB-101, ATB-1011, ATB-1012

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

Other names: ATB-1011 brand name: Olmetec, ATB-1012 brand name: Forxiga

Primary outcomes

  1. AUCt of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Area under the concentration-time curve

  2. Cmax of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Maximum concentration of drug in plasma

  3. AUCt of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Area under the concentration-time curve

  4. Cmax of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Maximum concentration of drug in plasma

Secondary outcomes

  1. AUC∞ of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Area under the plasma drug concentration-time curve from time 0 to infinity

  2. Tmax of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Time to maximum plasma concentration

  3. T1/2 of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Terminal elimination half-life

  4. CL/F of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Apparent total clearance of the drug from plasma after oral administration

  5. Vd/F of Olmesartan

    Time frame: Day1(first stage), Day8(scond stage)

    Apparent volume of distribution after non-intravenous administration

  6. AUC∞ of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Area under the plasma drug concentration-time curve from time 0 to infinity

  7. Tmax of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Time to maximum plasma concentration

  8. T1/2 of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Terminal elimination half-life

  9. CL/F of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Apparent total clearance of the drug from plasma after oral administration

  10. Vd/F of Dapagliflozin

    Time frame: Day1(first stage), Day8(scond stage)

    Apparent volume of distribution after non-intravenous administration

Sponsors and collaborators

Lead sponsor

Autotelicbio

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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