Approval Probability
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Adjusted LOA
ML Risk
Vycavert · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A: single dose Vycavert (Test) | EXPERIMENTAL | - |
| B: single dose Norco (Reference) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Vycavert | DRUG | single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen |
| Norco | DRUG | single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant disease * History of obstructive s...
Vycavert is an investigational small molecule drug being developed by Pfizer, Inc. (ticker PFE). It is in Phase 1 clinical development. The therapeutic area and the specific medical conditions it is intended to treat have not been publicly disclosed. One Phase 1 trial of Vycavert has been completed.
Vycavert is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical program studying the drug. The asset is a small molecule in Phase 1 development.
Vycavert is in Phase 1 clinical development. It is an investigational drug and is not approved. One Phase 1 trial has been completed, and no trials are currently active. That completed study enrolled 47 participants.
Vycavert has been studied in one completed Phase 1 trial, NCT01456520. That trial evaluated the pharmacokinetics and bioequivalence of Vycavert, a 10 mg hydrocodone bitartrate and 325 mg acetaminophen formulation, compared with the reference drug Norco. It enrolled 47 healthy adult volunteers in the United States and was active controlled and randomized.
Vycavert is not the same as Norco. Vycavert is the name of the investigational product developed by Pfizer, while Norco is the reference drug used for comparison in the completed Phase 1 bioequivalence trial, NCT01456520. That study compared a 10 mg hydrocodone bitartrate and 325 mg acetaminophen Vycavert formulation against Norco.
The completed Phase 1 trial of Vycavert, NCT01456520, was a randomized, active controlled study comparing Vycavert, a 10 mg hydrocodone bitartrate and 325 mg acetaminophen formulation, with the reference drug Norco. It enrolled 47 healthy volunteers aged 18 years and older in the United States and was not double blinded.