To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

NCT06361277 — Phase 1, Completed, 56 participants, JW Pharmaceutical

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A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers

Registry	NCT06361277
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: none, other
Enrollment	56 (Actual)
Sponsor	JW Pharmaceutical (Industry)
Conditions	Healthy
Interventions	Reference Drug or Test Drug (Drug)
Dates	start 2023-11-03, primary completion 2023-11-20, completion 2023-11-27, first posted 2024-04-11, last updated 2024-04-11
Locations	1 site in South Korea

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Other	Drug: Reference Drug or Test Drug	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
Group 2	Other	Drug: Reference Drug or Test Drug	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

Reference Drug or Test Drug (Drug), also known as Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202): Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

+Outcome measures

Primary outcomes

AUCt [Day1 0h ~ Day3 48h]: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Cmax [Day1 0h ~ Day3 48h]: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

+Eligibility

Sex: All, ages: 19 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

+Locations (1)

Facility	City	Country	Status
Clinical Trial Center, Jeonbuk National University Hospital	Jeonju	South Korea

+Investigators

MinGul Kim, Principal investigator, Jeonbuk National University Hospital