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Completed

NCT Number: NCT06754943

To Evaluate the Safety and PK Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 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

Metro Hospital

Anyang-si, Gyeonni-do, 14096, South Korea

About this study

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and 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_Period 1

Drug
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment B_Period 2

Drug
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment A_Period 3

Drug
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment B_Period 4

Drug
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment B_Period 1

Drug
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment A_Period 2

Drug
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment B_Period 3

Drug
  • Administration alone of 1 tablet of JW0105
  • Wash-out period: 21 days
  • Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Treatment A_Period 4

Drug
  • Co-administration of 1 tablet of JW0104 and 1 tablet of C2402
  • Wash-out period: 21 days
  • Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Other names: NA (Not Applicable)

Primary outcomes

  1. AUCt

    Time frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4

    Plasma concentrations are measured using a validated LC-MS/MS.

  2. Cmax

    Time frame: Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4

    Plasma concentrations are measured using a validated LC-MS/MS.

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, 2x4 Replicate Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0104 and C2402 and Administration of JW0105 in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 1, 2025
Registry last updated
Sep 9, 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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