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

Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548678

Enrollment

Registered

2007-10-24

Start date

2007-10-31

Completion date

2007-11-30

Last updated

2008-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

diclofenac, platelet aggregation, ketorolac, aspirin

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.

Interventions

DRUGintravenous diclofenac sodium (DIC075V)

intravenous diclofenac sodium

DRUGketorolac

intravenous ketorolac

DRUGoral diclofenac (Cataflam)

oral diclofenac (Cataflam)

DRUGaspirin

oral aspirin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.	6 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026