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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606059
First Posted: May 25, 2012
Last Update Posted: October 12, 2016
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.
Collaborator:
Chungnam National University Hospital
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
  Purpose
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 Intervention Phase
Healthy Drug: DW-0920 Drug: DW-0919 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

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

Enrollment: 30
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.


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.
  Contacts and Locations
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
Korea, Republic of
Chungnam National University Hospital
DaeJeon, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
Chungnam National University Hospital
  More Information

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01606059     History of Changes
Other Study ID Numbers: DW0919-1003
First Submitted: May 23, 2012
First Posted: May 25, 2012
Last Update Posted: October 12, 2016
Last Verified: October 2016

Additional relevant 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