UMIN ID: UMIN000002559
Registered date:01/10/2009
A randomized, quadruple crossover single-blind study on immediate action of Bufferin 81mg tablets and Bayaspirin 100mg in healthy volunteers
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Acute myocardial infarction |
| Date of first enrollment | 2009/10/01 |
| Target sample size | 12 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Bufferin 81mg tablets, just swallowed > washout for 2 weeks > Bufferin 81mg tablets, chewed and then swallowed > washout for 2 weeks > Bayaspirin 100mg, just swallowed > washout for 2 weeks > Bayaspirin 100mg, chewed and then swallowed Bufferin 81mg tablets, chewed and then swallowed > washout for 2 weeks > Bufferin 81mg tablets, just swallowed > washout for 2 weeks > Bayaspirin 100mg, chewed and then swallowed > washout for 2 weeks > Bayaspirin 100mg, just swallowed Bayaspirin 100mg, just swallowed > washout for 2 weeks > Bayaspirin 100mg, chewed and then swallowed > washout for 2 weeks > Bufferin 81mg tablets, just swallowed > washout for 2 weeks > Bufferin 81mg tablets, chewed and then swallowed Bayaspirin 100mg, chewed and then swallowed > washout for 2 weeks > Bayaspirin 100mg, just swallowed > washout for 2 weeks > Bufferin 81mg tablets, chewed and then swallowed > washout for 2 weeks > Bufferin 81mg tablets, just swallowed |
Outcome(s)
| Primary Outcome | Time-course of platelet aggregation inhibition |
|---|---|
| Secondary Outcome | Time-course of plasma concentration of aspirin after oral administration, pharmacokinetic parameters (Tmax, AUC), Time-course of plasma TXB2 level |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 50years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Kanazawa University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshimichi Sai |
| Address | Japan |
| Telephone | 076-265-2046 |
| sai-ys@staff.kanazawa-u.ac.jp | |
| Affiliation | Kanazawa University Hospital Department of Pharmacy |
| scientific contact | |
| Name | Ken-ichi Miyamoto |
| Address | 13-1 Takara-machi, Kanazawa 920-8641 Japan |
| Telephone | 076-265-2045 |
| Affiliation | Kanazawa University Hospital Department of Pharmacy |