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To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361277
Enrollment
56
Registered
2024-04-11
Start date
2023-11-03
Completion date
2023-11-27
Last updated
2024-04-11

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 JW0202 and C2202 and co-administration of C2205 and JW0201 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.

Interventions

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
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
AUCtDay1 0h ~ Day3 48hDescribes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.
CmaxDay1 0h ~ Day3 48hDescribes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Countries

South Korea

Outcome results

None listed

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