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NCT00864149
A Two-Way Crossover, Open-Label, Single Dose, Fed, Bioequivalence Study of Carvedilol 12.5 mg Tablets Versus Coreg® 12.5 mg Tablets in Normal, Healthy, Non-Smoking Male and Female Subjects
Phase 1 trial testing Carvedilol 12.5 mg Tablets, single dose in Healthy in 36 participants. Completed in 1 November 2005.
1 November 2005
Quick facts
| Lead sponsor | Actavis Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 36 |
| Start date | 1 October 2005 |
| Primary completion | 1 November 2005 |
| Estimated completion | 1 November 2005 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Carvedilol 12.5 mg Tablets, single dose — full drug profile →
- Coreg® 12.5 mg Tablets , single dose — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Actavis 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.
-
Rate and Extend of Absorption
Time frame: 36 hours
Sponsor's own description
To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets 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 NCT00864149
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Actavis 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 NCT00864149 (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 Actavis Inc.
- Last refreshed: 13 August 2010
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/NCT00864149.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing