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.

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.

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Apr 2012

At a glance

  • Drugs Aspirin; Aspirin/esomeprazole; Esomeprazole
  • Indications Bleeding ulcer; Cardiovascular disorders; Embolism and thrombosis; Gastro-oesophageal reflux; Helicobacter infections; NSAID-induced gastrointestinal damage; Peptic ulcer; Reflux oesophagitis
  • Focus Pharmacokinetics
  • Most Recent Events

    • 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.
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