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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Reference Drug or Test Drug

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Clinical Trial Center, Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Subjects does not meet the Inclusion Criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Drug: Reference Drug or Test Drug; Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration; Other Names: Reference Drug(JW0101 and C2101) or Test Drug(JW0102)
Other: 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	Drug: Reference Drug or Test Drug; Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration; Other Names: Reference Drug(JW0101 and C2101) or Test Drug(JW0102)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt	Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.	Day1 0h ~ Day4 72h
Cmax	Describes the blood concentration statistically by pharmacokinetic blood	Day1 0h ~ Day4 72h

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: SeolJu Moon, Jeonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JW22101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No