Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02369302
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWC20141; Drug: DWC20142; Drug: DWC20141, DWC20142	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Drug Interaction Between DWC20141 and DWC20142 in Healthy Adult Subjects
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWC20141 multiple dose of DWC20141	Drug: DWC20141; Tablet
Experimental: DWC20142 multiple dose of DWC20142	Drug: DWC20142; Tablet
Experimental: DWC20141+DWC20142 multiple dose of DWC20141 and DWC20142	Drug: DWC20141, DWC20142; Tablet

Outcome Measures

Primary Outcome Measures

1. Cmax,ss [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

2. AUCtau [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

Secondary Outcome Measures

1. Cmin,ss [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

2. Tmax [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

3. t1/2 [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

4. Metabolic Ratio [Multiple blood sample will be collected for 24 hours after last dosing in each of the periods]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years

2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result

3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.

2. A subject who shows the following result in clinical laboratory test

• AST, ALT > 1.25 times of the upper limit of normal range

• PR ≥ 210 msec

• QRS ≥ 120 msec

• QT ≥ 500 msec

• QTcF ≥ 500 msec

1. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

• Principal Investigator: Eun-Young Kim, Professor, BUSAN PAIK HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT02369302
• Other Study ID Numbers: DW_DWJ1367001
• First Posted: Feb 23, 2015
• Last Update Posted: Mar 1, 2016
• Last Verified: Feb 1, 2016

Study Results

No Results Posted as of Mar 1, 2016