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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754943
Enrollment
60
Registered
2025-01-01
Start date
2025-01-17
Completion date
2025-04-22
Last updated
2025-09-09

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 characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.

Detailed description

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

Interventions

DRUGTreatment A_Period 1

* 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

DRUGTreatment B_Period 2

* 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

DRUGTreatment A_Period 3

* 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

DRUGTreatment B_Period 4

* 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

DRUGTreatment B_Period 1

* 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

DRUGTreatment A_Period 2

* 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

DRUGTreatment B_Period 3

* 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

DRUGTreatment A_Period 4

* 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

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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

MeasureTime frameDescription
AUCtDay 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4Plasma concentrations are measured using a validated LC-MS/MS.
CmaxDay 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4Plasma concentrations are measured using a validated LC-MS/MS.

Countries

South Korea

Outcome results

None listed

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