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NCT01456520
An Open Label, Single Dose, Randomized, Two-Period, Two-Way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Vycavert Tablets Compared to Norco® Tablets in Healthy Subjects
Phase 1 trial testing Vycavert in Healthy in 47 participants. Completed in 1 January 2012.
1 January 2012
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 47 |
| Start date | 1 October 2011 |
| Primary completion | 1 January 2012 |
| Estimated completion | 1 January 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — 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.
-
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone.
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose -
Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of acetaminophen
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose -
Cmax (maximum plasma concentration) of of hydrocodone
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose -
Cmax (maximum plasma concentration) of acetaminophen
Time frame: 0, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose
Sponsor's own description
This study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of Vycavert are comparable to those following oral dosing of Norco.
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 NCT01456520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01456520 (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 Pfizer
- Last refreshed: 7 February 2012
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/NCT01456520.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing