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NCT00649168
Study of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg Bromocriptine Mesylate Capsules Following a 10 mg Dose in Healthy Adult Volunteers Under Fed Conditions
Phase 1 trial testing BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg in Healthy in 120 participants. Completed in 1 June 2007.
1 June 2007
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 | 120 |
| Start date | 1 April 2007 |
| Primary completion | 1 June 2007 |
| Estimated completion | 1 June 2007 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg — full drug profile →
- Parlodel® (bromocriptine mesylate) capsules, USP 5 mg — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Mylan Pharmaceuticals Inc — full company profile →
Who can join
Adults 18 to 45, 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 assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed 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 NCT00649168
- 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
Trials by the same sponsor.
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- NCT03610646 — Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (D · Phase 3 · completed
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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 NCT00649168 (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/NCT00649168.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing