To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B: JW0107 1 tablet; Drug: Treatment A: JW0106 1 tablet + C2101 1 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06816719

JW24107

Details and patient eligibility

About

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 in healthy volunteers under fasting conditions.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy volunteers

Exclusion criteria

Subjects does not meet the inclusion Criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Sequence 1

Other group

Description:

(Period 1/3: Treatment A) (Period 2/4: Treatment B) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

Treatment:

Drug: Treatment A: JW0106 1 tablet + C2101 1 tablet

Drug: Treatment B: JW0107 1 tablet

Sequence 2

Other group

Description:

(Period 1/3: Treatment B) (Period 2/4: Treatment A) Treatment A: JW0106 1 tablet + C2101 1 tablet Treatment B: JW0107 1 tablet

Treatment:

Drug: Treatment A: JW0106 1 tablet + C2101 1 tablet

Drug: Treatment B: JW0107 1 tablet