Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition (DW0919-1003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606059
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Chungnam National University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: DW-0920 Drug: DW-0919 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers
Study Start Date : May 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Active Comparator: DW-0919 Drug: DW-0919
Dosage form: Extended release tablet Dosage: 1 tablet
Other Names:
  • Acetaminophen: 650mg
  • Tramadol: 75mg

Experimental: DW-0920 Drug: DW-0920
Dosage form: Extended release tablet Dosage: 2 tablets
Other Names:
  • Acetaminophen: 325mg
  • Tramadol: 37.5mg
  • Wontran ER tab.




Primary Outcome Measures :
  1. AUC of DW-0919(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ]
  2. Cmax of DW-0919(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ]
  3. AUC of DW-0920(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ]
  4. Cmax of DW-0920(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606059


Locations
Layout table for location information
Korea, Republic of
Chungnam National University Hospital
DaeJeon, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
Chungnam National University Hospital

Layout table for additonal information
Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01606059     History of Changes
Other Study ID Numbers: DW0919-1003
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Tramadol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants