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OpenTrials
Completed

NCT Number: NCT06355349

To Evaluate the Safety and PK Characteristics in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Subjects does not meet the Inclusion Criteria

Treatment and study plan

Reference Drug or Test Drug

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)

Primary outcomes

  1. AUCt

    Time frame: Day1 0h ~ Day4 72h

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

  2. Cmax

    Time frame: Day1 0h ~ Day4 72h

    Describes the blood concentration statistically by pharmacokinetic blood

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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