Skip to main content
OpenTrials
Completed

NCT Number: NCT05463497

To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk National University Hospita

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

  • To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
  • To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Subjects does not meet the Inclusion Criteria

Treatment and study plan

Treatment A

Drug

JW0201: single administration, Tablet, Oral, BID for 5 days

Treatment B

Drug

C2103: single administration, Tablet, Oral, BID for 5 days

Treatment C

Drug

JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days

Treatment D

Drug

C2104 : single administration, Tablet, Oral, QD for 5 days

Treatment E

Drug

JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Primary outcomes

  1. Cmax,ss

    Time frame: up to 12hour(or 24hour) after administration

    Cmax,ss of each drug

  2. AUCτ,ss

    Time frame: up to 12hour(or 24hour) after administration

    AUCτ,ss of each drug

Secondary outcomes

  1. Cmin,ss

    Time frame: up to 12hour(or 24hour) after administration

    Cmin,ss of each drug

  2. Tmax,ss

    Time frame: up to 12hour(or 24hour) after administration

    Tmax,ss of each drug

  3. CLss/F

    Time frame: up to 12hour(or 24hour) after administration

    CLss/F of each drug

  4. Vdss/F

    Time frame: up to 12hour(or 24hour) after administration

    Vdss/F of each drug

  5. fluctuation

    Time frame: up to 12hour(or 24hour) after administration

    fluctuation of each drug

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Jul 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.