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Completed

NCT Number: NCT06816719

To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 in healthy volunteers under fasting conditions.

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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, Jeonbuk National University Hospital

Jeonju, Korea, South Korea

About this study

Pharmacokinetic characteristics: 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

Treatment A: JW0106 1 tablet + C2101 1 tablet

Drug
  • Co-administration of 1 tablet of JW0106 and 1 tablet of C2101
  • Administration orally with 150 mL of water under fasting conditions

Treatment B: JW0107 1 tablet

Drug
  • Administration alone of 1 tablet of JW0107
  • Administration orally with 150 mL of water under fasting conditions

Other names: Administration alone of 1 tablet of JW0107

Primary outcomes

  1. AUCt

    Time frame: Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)

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

  2. Cmax

    Time frame: Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)

    Describes the blood concentration statistically by pharmacokinetic blood

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0106 and C2101 and Administration of JW0107 in Healthy Volunteers Under Fasting Conditions

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

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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