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Completed

NCT Number: NCT02369302

Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University College of Medicine Busan Paik Hospital

Busan, Busanjin-gu, 614-735, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult male volunteers aged 19 to 45 years
  • A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
  • A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion criteria

  • A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
  • A subject who shows the following result in clinical laboratory test
  • AST, ALT > 1.25 times of the upper limit of normal range
  • PR ≥ 210 msec
  • QRS ≥ 120 msec
  • QT ≥ 500 msec
  • QTcF ≥ 500 msec
  • Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Treatment and study plan

DWC20141

Drug

Tablet

DWC20142

Drug

Tablet

DWC20141, DWC20142

Drug

Tablet

Primary outcomes

  1. Cmax,ss

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  2. AUCtau

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Secondary outcomes

  1. Cmin,ss

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  2. Tmax

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  3. t1/2

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

  4. Metabolic Ratio

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2015
Registry last updated
Mar 1, 2016

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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