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Completed

NCT Number: NCT05465668

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics of DWP16001 Drug A and C

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug C in healty adult volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA unuversity bundang medical center

Seongnam, South Korea

About this study

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWP16001.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2

Exclusion criteria

  • musculoskeletal diseases
  • mental diseases
  • hemato-oncologic diseases

Treatment and study plan

DWP16001 Drug A

Drug

DWP16001 Drug A

DWP16001 Drug C

Drug

DWP16001 Drug C

Primary outcomes

  1. Cmax,ss of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    Peak Plasma Concetration of DWP16001

  2. AUClast of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    The area under the plasma drug concentration-time curve of DWP16001

Secondary outcomes

  1. Tmax of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    Time at Cmax of DWP16001

  2. T1/2 of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    Half life of DWP16001

  3. CL/F of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    Apparent total clearance of the drug from plasma after oral administration of DWP16001

  4. Vd/F of DWP16001

    Time frame: At pre-dose (0 hour), and post-dose 0.25 to 72 hour.

    Volume of distribution of DWP16001

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 C in Healthy Adult Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
Jan 31, 2023

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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