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NCT00802451
A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
NA trial testing Mesalamine in Healthy in 48 participants. Completed in 1 March 2003.
1 March 2003
Quick facts
| Lead sponsor | Padagis LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 February 2003 |
| Primary completion | 1 March 2003 |
| Estimated completion | 1 March 2003 |
Drugs / interventions tested
- Mesalamine — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Padagis LLC — full company profile →
Who can join
Adults 18 to 55, 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 was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Sponsor's own description
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.
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 NCT00802451
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Padagis LLC trials
Trials by the same sponsor.
- NCT05763082 — Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis · Phase 3 · completed
- NCT04944290 — To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocul · Phase 3 · completed
- NCT04155203 — To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Secondarily Infe · Phase 3 · completed
- NCT04024072 — To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocul · Phase 3 · completed
- NCT03393494 — Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face · Phase 3 · completed
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 NCT00802451 (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 Padagis LLC
- Last refreshed: 7 October 2021
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/NCT00802451.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing