MedPath

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Registration Number
NCT06378684
Lead Sponsor
JW Pharmaceutical
Brief Summary

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Detailed Description

Pharmacokinetic Interactions: 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Healthy volunteers
Exclusion Criteria
  • Subjects does not meet the Inclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Primary Outcome Measures
NameTimeMethod
Cmax,ssDay 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

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

AUCτ,ssDay 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Clinical Trial Center, Severance Hospital

🇰🇷

Seoul, Korea, Republic of

Clinical Trial Center, Severance Hospital
🇰🇷Seoul, Korea, Republic of
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