Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00548678
- Lead Sponsor
- Javelin Pharmaceuticals
- Brief Summary
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
- Detailed Description
The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
- Healthy male subjects.
- Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.
Exclusion Criteria
- Bleeding abnormalities or cardiovascular events.
- Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A intravenous diclofenac sodium (DIC075V) intravenous diclofenac sodium D aspirin oral aspirin C oral diclofenac (Cataflam) oral diclofenac (Cataflam) B ketorolac intravenous ketorolac
- Primary Outcome Measures
Name Time Method Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100. 6 hours
- Secondary Outcome Measures
Name Time Method The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100. 6 hours
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of diclofenac sodium on platelet cyclooxygenase inhibition compared to ketorolac tromethamine?
How does intravenous diclofenac compare to oral formulations in platelet function suppression in healthy volunteers?
What biomarkers correlate with differential platelet response to NSAIDs like diclofenac and ketorolac in phase 1 trials?
What are the adverse event profiles of IV diclofenac sodium versus IV ketorolac in pain management settings?
How do Javelin Pharmaceuticals' NSAID formulations compare to competitor drugs in platelet inhibition efficacy?
Trial Locations
- Locations (1)
Comprehensive Phase One
🇺🇸Miramar, Florida, United States
Comprehensive Phase One🇺🇸Miramar, Florida, United States