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NCT00647816
Single-Dose Fasting Bioequivalence Study of Propranolol Hydrochloride Extended-Release Capsules (160 mg; Mylan) and Inderal® LA Capsules (160 mg; Wyeth) in Healthy Volunteers
Phase 1 trial testing Propranolol Hydrochloride Extended-Release Capsules 160 mg in Healthy in 100 participants. Completed in 1 September 2005.
1 September 2005
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 | 100 |
| Start date | 1 September 2005 |
| Primary completion | 1 September 2005 |
| Estimated completion | 1 September 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Propranolol Hydrochloride Extended-Release Capsules 160 mg
- Inderal® LA Capsules 160 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 propranolol hydrochloride extended-release 160 mg capsules to Wyeth's Inderal LA® 160 mg capsules following a single, oral 160 mg (1 x 160 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 NCT00647816
- 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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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 NCT00647816 (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/NCT00647816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing