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Sponsored by: |
Javelin Pharmaceuticals |
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Information provided by: | Javelin Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00474136 |
The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg Drug: Oral diclofenac potassium 50 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Open-Label, Randomized, Single Center Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses) Versus Oral Diclofenac Potassium in Healthy Adult Volunteers Following Single- and Multiple-Dose Administration |
Enrollment: | 36 |
Study Start Date: | March 2007 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Intravenous diclofenac sodium (DIC075V) 18.75 mg
DIC075V 18.75 mg
|
2: Experimental |
Drug: Intravenous diclofenac sodium (DIC075V) 37.5 mg
DIC075V 37.5 mg
|
3: Active Comparator |
Drug: Oral diclofenac potassium 50 mg
Oral diclofenac potassium 50 mg
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This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
PAREXEL International | |
Baltimore, Maryland, United States, 21225 |
Principal Investigator: | Terri Lunsford, MD | PAREXEL International |
Responsible Party: | Javelin Pharmaceuticals ( Amy Cohen ) |
Study ID Numbers: | DFC-PK-006 |
Study First Received: | May 14, 2007 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00474136 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Diclofenac Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Healthy Antirheumatic Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Diclofenac Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |