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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03016494

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Co-administration of DWC20155 and DWC20156 Drug: DWJ1386 Tab.	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test/Reference Drug DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.	Drug: Co-administration of DWC20155 and DWC20156 Drug: DWJ1386 Tab.
Experimental: Reference/Test Drug co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.	Drug: Co-administration of DWC20155 and DWC20156 Drug: DWJ1386 Tab.

Arm

Intervention/Treatment

Experimental: Test/Reference Drug

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

Drug: Co-administration of DWC20155 and DWC20156

Drug: DWJ1386 Tab.

Experimental: Reference/Test Drug

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

Drug: Co-administration of DWC20155 and DWC20156

Drug: DWJ1386 Tab.

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) [0-24 hours]
Area under the plasma concentration versus time curve (AUC) [0-24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Busan Paik Hospital	Busan	Busanjin-gu	Korea, Republic of	614-735

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT03016494

Other Study ID Numbers:

DW_DWJ1386001

First Posted:

Jan 10, 2017

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jan 10, 2017