Safety and Pharmacokinetics Study of DWC20155 and DWC20156 in Healthy Subjects

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Co-administration of DWC20155 and DWC20156; Drug: DWJ1366 Tab.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02952547

DW_DWJ1366002

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Test / Reference Drug

Experimental group

Description:

DWJ1366 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.

Treatment:

Drug: DWJ1366 Tab.

Drug: Co-administration of DWC20155 and DWC20156

Reference / Test Drug

Experimental group

Description:

Co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1366 Tab.

Treatment:

Drug: DWJ1366 Tab.

Drug: Co-administration of DWC20155 and DWC20156