A Phase 1 interventional study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg in Healthy, sponsored by Mylan Pharmaceuticals Inc. Completed at 1 site in United States. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Mylan Pharmaceuticals Inc · Phase 1, Interventional, and Other
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.
Mylan Pharmaceuticals Inc is the lead sponsor of 151 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rabeprazole Sodium Tablets 20 mg
Drug: Rabeprazole Sodium Tablets 20 mg
Aciphex® Tablets 20 mg
Drug: Aciphex® Tablets 20 mg
20mg, single dose fed
20mg, single dose fed
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Time frame: blood collections through 24 hours
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mylan Pharmaceuticals Inc