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

This study has been completed.
Chungnam National University Hospital
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd. Identifier:
First received: May 23, 2012
Last updated: January 21, 2013
Last verified: January 2013
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
Drug: DW-0920
Drug: DW-0919
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]
  • Cmax of DW-0919(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ] [ Designated as safety issue: No ]
  • AUC of DW-0920(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ] [ Designated as safety issue: No ]
  • Cmax of DW-0920(Acetaminophen, Tramadol) [ Time Frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 ] [ Designated as safety issue: No ]

Estimated 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.


Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01606059

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. Identifier: NCT01606059     History of Changes
Other Study ID Numbers: DW0919-1003 
Study First Received: May 23, 2012
Last Updated: January 21, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Analgesics, Opioid
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016