A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0101 and C2101 and Administration of JW0102 in Healthy Volunteers Under Fasting Conditions
Overview
- Phase
- Phase 1
- Intervention
- Reference Drug or Test Drug
- Conditions
- Healthy
- Sponsor
- JW Pharmaceutical
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- AUCt
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
Exclusion Criteria
- •Subjects does not meet the Inclusion Criteria
Arms & Interventions
Sequence A
Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
Intervention: Reference Drug or Test Drug
Sequence B
Treatment A: Co-administration of 1 tablet of JW0101 and 1 tablet of C2101 Treatment B: Administration alone of 1 tablet of JW0102 Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration
Intervention: Reference Drug or Test Drug
Outcomes
Primary Outcomes
AUCt
Time Frame: Day1 0h ~ Day4 72h
Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
Cmax
Time Frame: Day1 0h ~ Day4 72h
Describes the blood concentration statistically by pharmacokinetic blood