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Completed

NCT Number: NCT02502721

A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Busan Paik Hospital

Busan, South Korea

About this study

This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects (18~55 years)

Exclusion criteria

  • Who has allergy to investigational product

Treatment and study plan

DWC20151

Drug

DWC20152

Drug

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 0~72hr

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: 0~72h

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2015
Registry last updated
Aug 25, 2015

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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