Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

Javelin Pharmaceuticals30 enrolled

Overview

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.

The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

intravenous diclofenac sodium (DIC075V)DRUG

intravenous diclofenac sodium

ketorolacDRUG

intravenous ketorolac

oral diclofenac (Cataflam)DRUG

oral diclofenac (Cataflam)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Comprehensive Phase One

Miramar, Florida, United States

Outcomes

Primary Outcomes

Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.

Time frame: 6 hours

Secondary Outcomes

The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.

Time frame: 6 hours

Data from ClinicalTrials.gov

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