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CompletedNCT06816719Updated Feb 10, 2025

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

A Phase 1 interventional study of Treatment A: JW0106 1 tablet + C2101 1 tablet and Treatment B: JW0107 1 tablet in Healthy, sponsored by JW Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by JW Pharmaceutical · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2024, registered Jan 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy volunteers

Exclusion criteria

Exclusion Criteria:

Subjects does not meet the inclusion Criteria

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Other
    Sequence 1

    (Period 1/3: Treatment A) (Period 2/4: Treatment B) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

    Drug: Treatment A: JW0106 1 tablet + C2101 1 tablet · Drug: Treatment B: JW0107 1 tablet

  • Other
    Sequence 2

    (Period 1/3: Treatment B) (Period 2/4: Treatment A) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

    Drug: Treatment A: JW0106 1 tablet + C2101 1 tablet · Drug: Treatment B: JW0107 1 tablet

Interventions

  • DrugTreatment A: JW0106 1 tablet + C2101 1 tablet

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

  • DrugTreatment B: JW0107 1 tablet

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

    Also known as: Administration alone of 1 tablet of JW0107

06

What researchers measure

Primary outcomes

  1. AUCt

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

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

  2. Cmax

    Describes the blood concentration statistically by pharmacokinetic blood

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

07

Study locations

1 site
  • Clinical Trial Center, Jeonbuk National University Hospital
    Jeonju, Korea, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06816719
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Feb 10, 2025
Start date
Sep 2, 2024
Primary completion
Nov 2, 2024
Completion
Nov 12, 2024
Last update
Feb 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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