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CompletedNCT06361277Updated Apr 11, 2024

To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

A Phase 1 interventional study of Reference Drug or Test Drug in Healthy, sponsored by JW Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.

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

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2023, registered Mar 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
56
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 JW0202 and C2202 and co-administration of C2205 and JW0201 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 77 studies on the registry; 6 are open to participants now.

Browse JW Pharmaceutical studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Other
    Group 1

    Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

    Drug: Reference Drug or Test Drug

  • Other
    Group 2

    Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

    Drug: Reference Drug or Test Drug

Interventions

  • DrugReference Drug or Test Drug

    Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

    Also known as: Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)

06

What researchers measure

Primary outcomes

  1. AUCt

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

    Time frame: Day1 0h ~ Day3 48h

  2. Cmax

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

    Time frame: Day1 0h ~ Day3 48h

07

Study locations

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Nov 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
Apr 11, 2024
StartActual
Nov 3, 2023
Primary completionActual
Nov 20, 2023
CompletionActual
Nov 27, 2023
Last update
Apr 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06361277
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Nov 3, 2023
Primary completion
Nov 20, 2023
Completion
Nov 27, 2023
Last update
Apr 11, 2024

Study contacts

MinGul Kim
principal investigator · Jeonbuk National University Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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