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Completed

NCT Number: NCT01606059

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

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

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital

Daejeon, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DW-0920

Drug

Dosage form: Extended release tablet Dosage: 2 tablets

Other names: Acetaminophen: 325mg, Tramadol: 37.5mg, Wontran ER tab.

DW-0919

Drug

Dosage form: Extended release tablet Dosage: 1 tablet

Other names: Acetaminophen: 650mg, Tramadol: 75mg

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Chungnam National University Hospital

Registry information

Official study 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

Acronym: DW0919-1003

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 25, 2012
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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