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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWC20152; Drug: DWC20151

Study type: Interventional

Funder types: Industry

Identifiers

NCT02502721

DWJ1373001

Details and patient eligibility

About

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

Full 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).

Enrollment: 58 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects (18~55 years)

Exclusion criteria

• Who has allergy to investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Part A

Experimental group

Description:

To study effect of DWC20151 on DWC20152 PK

Treatment:

Drug: DWC20151

Part B

Experimental group

Description:

To study effect of DWC20152 on DWC20151 PK

Treatment:

Drug: DWC20152