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S(+)-Ibuprofen Effects on Asprin Treated Volunteers

Double Blind, Randomised, Parallel Group, Placebo Controlled Clinical Trial of S(+)-Ibuprofen Effects on TxB2 Concentrations and Platelet Aggregation in Aspirin-treated Healthy Adult Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00442585
Enrollment
72
Registered
2007-03-02
Start date
2006-09-30
Completion date
2007-10-31
Last updated
2012-03-13

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

Conditions

Drug Interactions

Brief summary

The purpose of this clinical trial is to determine whether S(+)-ibuprofen affect the platelet inhibition under steady state acetylsalicylic acid conditions.

Interventions

DRUGS(+)-ibuprofen

Sponsors

Gebro Pharma GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy caucasian volunteer * Must be able to swallow tablets

Exclusion criteria

* Underlying diseases * Ulcus pepticum in history * Abuse of alcoholic beverages (40g/d) * Hypersensitivity to investigational medicinal products

Design outcomes

Primary

MeasureTime frame
Percentage of inhibition of TxB2 after 1, 3, 7 and 10 days

Secondary

MeasureTime frame
percentage of subjects with >90% inhibition of TxB2, CEPI-CT and CADP-CT measured by PAF100,
prostacyclin metabolite

Countries

Austria

Outcome results

None listed

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