Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition
DW0919-1003
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
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2012
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 12, 2016
October 1, 2016
1 month
May 23, 2012
October 11, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
AUC of DW-0919(Acetaminophen, Tramadol)
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0919(Acetaminophen, Tramadol)
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
AUC of DW-0920(Acetaminophen, Tramadol)
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0920(Acetaminophen, Tramadol)
0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Study Arms (2)
DW-0919
ACTIVE COMPARATORDW-0920
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam National University Hospital
Daejeon, South Korea
Related Publications (1)
Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27.
PMID: 35800670DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 25, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 12, 2016
Record last verified: 2016-10