Skip to main content
OpenTrials
Completed

NCT Number: NCT06378684

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

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

Clinical Trial Center, Severance Hospital

Seoul, South Korea

About this study

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

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

Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)

Drug

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Primary outcomes

  1. Cmax,ss

    Time frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

  2. AUCτ,ss

    Time frame: Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Apr 22, 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.

Related clinical trials

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