Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DWJ1386 Tab.; Drug: Co-administration of DWC20155 and DWC20156

Study type: Interventional

Funder types: Industry

Identifiers

NCT03016494

DW_DWJ1386001

Details and patient eligibility

About

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

Enrollment: 56 estimated 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: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Test/Reference Drug

Experimental group

Description:

DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.

Treatment:

Drug: DWJ1386 Tab.

Drug: Co-administration of DWC20155 and DWC20156

Reference/Test Drug

Experimental group

Description:

co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.

Treatment:

Drug: DWJ1386 Tab.

Drug: Co-administration of DWC20155 and DWC20156