Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition
Information source: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: DW-0920 (Drug); DW-0919 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Daewon Pharmaceutical Co., Ltd.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: AUC of DW-0919(Acetaminophen, Tramadol)Cmax of DW-0919(Acetaminophen, Tramadol) AUC of DW-0920(Acetaminophen, Tramadol) Cmax of DW-0920(Acetaminophen, Tramadol)
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
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.
Locations and Contacts
Chungnam National University Hospital, DaeJeon, Korea, Republic of
Additional Information
Starting date: May 2012
Last updated: January 21, 2013
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