Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium (DFC-PK-008)
This study has been completed.
Sponsor:
Javelin Pharmaceuticals
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00509743
First received: July 27, 2007
Last updated: February 11, 2009
Last verified: February 2009
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Purpose
The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Intravenous diclofenac sodium (DIC075V) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | An Open-Label, Single-Dose Study to Assess the Effects of Age, Weight, and Body Composition on the Pharmacokinetic Profile, Safety, and Tolerability of Intravenous Diclofenac Sodium (DIC075V) in Adult Volunteers |
Resource links provided by NLM:
Further study details as provided by Javelin Pharmaceuticals:
Primary Outcome Measures:
- To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 89 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Low dose Diclofenac
|
Drug: Intravenous diclofenac sodium (DIC075V)
Low Dose Diclofenac
|
|
Experimental: B
High dose Diclofenac
|
Drug: Intravenous diclofenac sodium (DIC075V)
High dose Diclofenac
|
Detailed Description:
This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adult volunteers over age 18
Exclusion Criteria:
- Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation
- History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509743
Locations
| United States, Florida | |
| Comprehensive Phase One | |
| Miramar, Florida, United States, 33025 | |
| United States, Maryland | |
| PAREXEL International | |
| Baltimore, Maryland, United States, 21225 | |
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
| Principal Investigator: | D. Ronald Goldwater, MD | PAREXEL International |
| Principal Investigator: | William Gerson, D.O. | Comprehensive Phase One |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gabrielle Poirier, Javelin Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00509743 History of Changes |
| Other Study ID Numbers: | DFC-PK-008 |
| Study First Received: | July 27, 2007 |
| Last Updated: | February 11, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Javelin Pharmaceuticals:
|
Adult volunteers |
Additional relevant MeSH terms:
|
Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013