To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06378684

Enrollment

48

Registered

2024-04-22

Start date

2023-09-10

Completion date

2024-01-13

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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.

Interventions

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

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

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

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

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

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

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

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

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

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

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

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

Sponsors

JW Pharmaceutical

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Subjects does not meet the Inclusion Criteria

Design outcomes

Primary

Measure	Time frame	Description
Cmax,ss	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.
AUCτ,ss	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026