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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02502721
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 28.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWC20151; Drug: DWC20152	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A To study effect of DWC20151 on DWC20152 PK	Drug: DWC20151
Experimental: Part B To study effect of DWC20152 on DWC20151 PK	Drug: DWC20152

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) [0~72hr]

2. Area under the plasma concentration versus time curve (AUC) [0~72h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects (18~55 years)

Exclusion Criteria:

• Who has allergy to investigational product

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Busan Paik Hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Jinah Jung, Busan paik hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT02502721
• Other Study ID Numbers: DWJ1373001
• First Posted: Jul 20, 2015
• Last Update Posted: Aug 25, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Daewoong Pharmaceutical Co. LTD.: Male

Study Results

No Results Posted as of Aug 25, 2015