NCT06355349

To Evaluate the Safety and PK Characteristics in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Reference Drug or Test Drug	Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Timeline

• Start date: 2023-04-28
• Primary completion: 2023-07-10
• Completion: 2023-07-17
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: South Korea