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NCT00648349
Single-Dose Fasting In Vivo Bioequivalence Study of Rabeprazole Sodium Delayed-Release Tablets (20 mg; Mylan) to Aciphex® Delayed-Release Tablets (20 mg; Eisia) in Healthy Volunteers
Phase 1 trial testing Rabeprazole Sodium Delayed-Release Tablets 20 mg in Healthy in 72 participants. Completed in 1 June 2003.
1 June 2003
Quick facts
| Lead sponsor | Mylan Pharmaceuticals Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 72 |
| Start date | 1 May 2003 |
| Primary completion | 1 June 2003 |
| Estimated completion | 1 June 2003 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rabeprazole Sodium Delayed-Release Tablets 20 mg — full drug profile →
- Aciphex® Delayed-Release Tablets 20 mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Mylan Pharmaceuticals Inc — full company profile →
Who can join
18 and older, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bioequivalence
Time frame: within 30 days
Sponsor's own description
The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00648349
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Mylan Pharmaceuticals Inc trials
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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 NCT00648349 (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 Mylan Pharmaceuticals Inc
- Last refreshed: 22 April 2024
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/NCT00648349.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing