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Vycavert

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 8, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

Vycavert · 1 trial · 1 indication

Phase 1 1
NCT01456520Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug NorcoHealthy
COMPLETED47 Analytics
PHASE1COMPLETED
Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco
Healthy
NCT0145652047
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Study Endpoints

Primary Endpoints

Area Under the Curve (AUC) to time infinity (inf) (if data permit), otherwise (AUC) to last quantifiable concentration (last) of hydrocodone.
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
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
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
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

Secondary Endpoints

AUClast of hydromorphone and norhydrocodone
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 of hydromorphone and norhydrocodone
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
T1/2 (half life) as data permit of hydrocodone, hydromorphone, norhydrocodone, and acetaminophen
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
A: single dose Vycavert (Test)EXPERIMENTAL -
B: single dose Norco (Reference)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
VycavertDRUGsingle dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
NorcoDRUGsingle dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Vycavert

What is Vycavert?

Vycavert is an investigational small molecule being developed by Pfizer, Inc. (NYSE: PFE). It is a combination product containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Vycavert is currently in Phase 1 clinical development and has not been approved by the FDA.

What is Vycavert used for?

Vycavert is being studied in healthy volunteers to assess its pharmacokinetics and bioequivalence compared to the reference drug Norco. The clinical trial enrolled healthy adults in the United States, with the goal of evaluating how the body processes the drug.

Who makes Vycavert?

Vycavert is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on this investigational combination product.

What phase is Vycavert in?

Vycavert is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug's pharmacokinetics and bioequivalence in healthy volunteers. The drug is investigational and has not received FDA approval.

What clinical trials is Vycavert in?

Vycavert has one completed clinical trial, NCT01456520, titled 'Pharmacokinetics and Bioequivalence of Vycavert (10 mg Hydrocodone Bitartrate/325 mg Acetaminophen) Compared to the Reference Drug Norco.' This Phase 1 study enrolled 47 healthy adults in the United States.

Is Vycavert the same as Norco?

Vycavert is not the same as Norco, but it is being studied as a potential generic equivalent. The clinical trial compared Vycavert, which contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen, to the reference drug Norco to assess bioequivalence.