Trial Profile
A Phase I, Open Label, Randomized, Single Center, 2 Way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) With a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects.
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 17 Apr 2012
Price :
$35
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At a glance
- Drugs Aspirin/esomeprazole (Primary) ; Aspirin; Esomeprazole
- Indications Bleeding ulcer; Cardiovascular disorders; Embolism and thrombosis; Gastro-oesophageal reflux; Helicobacter infections; NSAID-induced gastrointestinal damage; Peptic ulcer; Reflux oesophagitis
- Focus Pharmacokinetics
- 06 Apr 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 06 Apr 2012 Actual patient number 77 added as reported by ClinicalTrials.gov.
- 17 Jan 2012 Actual initiation date (Jan 2012) added as reported by ClinicalTrials.gov.