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OpenTrials
Completed

NCT Number: NCT05414591

Pharmacokinetics and Safety Following Administration of DWP16001

To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult volunteers aged ≥ 19 years at screening
  • Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
  • Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
  • Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.

Exclusion criteria

  • Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
  • Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
  • Clinical laboratory test values are outside the accepted normal range at screening
  • Other exclusive inclusion criteria, as defined in the protocol

Treatment and study plan

DWP16001 Drug A

Drug

1 tablet, Oral, once daily single dose

DWP16001 drug B

Drug

3 tablet, Oral, once daily single dose

Primary outcomes

  1. AUC0_t of DWP16001

    Time frame: 0-72 hours

    Area under the plasma concentration versus time curve

  2. Cmax of DWP16001

    Time frame: 0-72 hours

    Peak Plasma Concetration

Secondary outcomes

  1. Tmax Tmax

    Time frame: 0-72 hours

    Time at Cmax Tmax

  2. AUC of DWP16001

    Time frame: 0-72 hours

    Area under the plasma concentration versus time curve

  3. T 1/2 of DWP16001

    Time frame: 0-72 hours

    half life of DWP16001

  4. CL/F of DWP16001

    Time frame: 0-72 hours

    Apparent total clearance of the drug from plasma after oral administration

  5. Vd/F of DWP16001

    Time frame: 0-72 hours

    Volume of distribution

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DWP16001 Drug A and DWP16001 Drug B in Healthy Adult Volunteers

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2022
Registry last updated
Jul 13, 2022

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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