Last reviewed · How we verify
NCT01388660
A Randomized, Open-label, Single-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a Tablet Containing 75 mg of Clopidogrel and 100 mg of Aspirin and The Simultaneous Administration of The Separate Formulations of The Two Drugs in Healthy Male Volunteers
Phase 1 trial testing Cloas in Coronary Artery Disease in 60 participants. Status unknown.
1 September 2014
Quick facts
| Lead sponsor | Ajou University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 June 2011 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Cloas — full drug profile →
- Plavix/Astrix — full drug profile →
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Ajou University School of Medicine
Who can join
Adults 20 to 45, male only, with Coronary Artery Disease. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
Time frame: upto 24 hours after dosing
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
Sponsor's own description
This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin and the simultaneous administration of the separate formulations of the two drugs in healthy male volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01388660
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Ajou University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01388660 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ajou University School of Medicine
- Last refreshed: 25 March 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01388660.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing