To Evaluate the Safety and PK Characteristics in Healthy Volunteers

NCT ID: NCT06355349

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2023-07-17

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: DRUG

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

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

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: DRUG

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Interventions

Reference Drug or Test Drug

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Intervention Type: DRUG

Other Intervention Names

Reference Drug(JW0101 and C2101) or Test Drug(JW0102)

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeolJu Moon

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk National University Hospital

Locations

Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

JW22101

Identifier Type: -

Identifier Source: org_study_id