Healthy Subjects Clinical Trial
Official title:
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
NCT number | NCT01330472 |
Other study ID # | A6131025 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | June 2011 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 55 Years |
Eligibility | Inclusion Criteria: - Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive. - An informed consent document signed and dated by the subject. Exclusion Criteria: - Evidence or history of clinically significant abnormality. - A positive urine drug screen. - Subjects who are hypersensitive to alprazolam or related compounds. |
Country | Name | City | State |
---|---|---|---|
Singapore | Pfizer Investigational Site | Singapore |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve from time zero to infinity (AUCinf) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | ||
Primary | Peak plasma conc (Cmax) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | ||
Secondary | Area under the curve from zero to the last time point (AUClast) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | ||
Secondary | Area under the curve extrapolated (AUC%extrap) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | ||
Secondary | Terminal half life of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose | ||
Secondary | Time to peak concentration (Tmax) of alprazolam | Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose |
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