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A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers

A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers - A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002559
Enrollment
12
Registered
2009-10-01
Start date
2009-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute myocardial infarction

Interventions

Bufferin 81mg tablets, just swallowed &gt
washout for 2 weeks &gt
Bufferin 81mg tablets, chewed and then swallowed &gt
Bayaspirin 100mg, just swallowed &gt
Bayaspirin 100mg, chewed and then swallowed Bufferin 81mg tablets, chewed and then swallowed &gt
Bayaspirin 100mg, chewed and then swallowed &gt
Bayaspirin 100mg, just swallowed Bayaspirin 100mg, just swallowed &gt
Bufferin 81mg tablets, chewed and then swallowed Bayaspirin 100mg, chewed and then swallowed &gt

Sponsors

Kanazawa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers who 1) aged 20 to 50 years, both sexes 2) exhibited normal platelet aggregation in pre-examination 3) gave their written informed consent

Exclusion criteria

Exclusion criteria: 1) history of hypersensitivity to ingredients of Bufferin 81mg tablets, Bayaspirin 100mg or salicylic acid formulation 2) history of aspirin asthma 3) use of non-steroidal anti-inflammatory drugs (NSAIDs) within past 2 weeks 4) antiplatelet agent dosed within past 2 weeks 5) anticoagulation drug dosed within past 2 weeks 6) odontectomy or other invasive operation scheduled within past 2 weeks 7) peptic ulcer disease 8) pregnancy, parturition or lactation 9) bleeding tendency 10) hypermenorrhea 11) drink alcohol on a regular basis 12) reflux esophagitis 13) other situation that doctor decides

Design outcomes

Primary

MeasureTime frame
Time-course of platelet aggregation inhibition

Secondary

MeasureTime frame
Time-course of plasma concentration of aspirin after oral administration, pharmacokinetic parameters (Tmax, AUC), Time-course of plasma TXB2 level

Countries

Japan

Contacts

Public ContactYoshimichi Sai

Kanazawa University Hospital Department of Pharmacy

sai-ys@staff.kanazawa-u.ac.jp076-265-2046

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026