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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWC20151; Drug: DWC20152

• Registration Number: NCT02502721
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

Inclusion Criteria

• Healthy male subjects (18~55 years)

Exclusion Criteria

• Who has allergy to investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A	DWC20151	To study effect of DWC20151 on DWC20152 PK
Part B	DWC20152	To study effect of DWC20152 on DWC20151 PK

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	0~72hr
Area under the plasma concentration versus time curve (AUC)	0~72h

Trial Locations

Locations (1)

Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of