Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DW-0920; Drug: DW-0919

• Registration Number: NCT01606059
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Adult males aged 20 to 55 years at screening.
• No significant congenital/chronic disease.
• No symptoms in physical examination.
• Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
• Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria

• History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
• History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
• History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DW-0920	DW-0920	-
DW-0919	DW-0919	-

Primary Outcome Measures

Name	Time	Method
AUC of DW-0919(Acetaminophen, Tramadol)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0919(Acetaminophen, Tramadol)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
AUC of DW-0920(Acetaminophen, Tramadol)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0920(Acetaminophen, Tramadol)	0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 DaeJeon, Korea, Republic of