To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05463497

Enrollment

Registered

2022-07-19

Start date

2022-01-17

Completion date

2022-03-23

Last updated

2022-07-19

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

Conditions

Healthy

Brief summary

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Detailed description

1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults. 2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Interventions

DRUGTreatment A

JW0201: single administration, Tablet, Oral, BID for 5 days

DRUGTreatment B

C2103: single administration, Tablet, Oral, BID for 5 days

DRUGTreatment C

JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days

DRUGTreatment D

C2104 : single administration, Tablet, Oral, QD for 5 days

DRUGTreatment E

JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Intervention model description

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial

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	up to 12hour(or 24hour) after administration	Cmax,ss of each drug
AUCτ,ss	up to 12hour(or 24hour) after administration	AUCτ,ss of each drug

Secondary

Measure	Time frame	Description
Cmin,ss	up to 12hour(or 24hour) after administration	Cmin,ss of each drug
Tmax,ss	up to 12hour(or 24hour) after administration	Tmax,ss of each drug
CLss/F	up to 12hour(or 24hour) after administration	CLss/F of each drug
Vdss/F	up to 12hour(or 24hour) after administration	Vdss/F of each drug
fluctuation	up to 12hour(or 24hour) after administration	fluctuation of each drug

Countries

South Korea

Outcome results

None listed

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