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Completed

NCT Number: NCT02952547

Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects

The purpose of this study to Compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Completed

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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

Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI ≥ 18.5 and ≤ 27.0 kg/m2.
  • No clinically significant findings
  • Age 19-55 years at screening

Exclusion criteria

  • Who has allergy to investigational product

Treatment and study plan

Co-administration of DWC20155 and DWC20156

Drug

DWJ1366 Tab.

Drug

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 0-24 hours

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

    Time frame: 0-24 hours

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Randomized, Open-label, Oral Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between Co-administration and Fixed Dose Combination of DWC20155 and DWC20156 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Feb 16, 2017

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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