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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:
Collaborator:
Chungnam National University Hospital
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01606059
First received: May 23, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov 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:
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013