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OpenTrials
Completed

NCT Number: NCT01330472

An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites

Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.

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Key information

Conditions

Healthy Subjects

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xanax XR tablets 3 mg (sourced from Caugus)

Drug

Tablets, 3 mg, single dose

Xanax XR tablets 3 mg (sourced from Barceloneta)

Drug

Tablets, 3 mg, single dose

Primary outcomes

  1. Area under the curve from time zero to infinity (AUCinf) of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

  2. Peak plasma conc (Cmax) of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

Secondary outcomes

  1. Area under the curve from zero to the last time point (AUClast) of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

  2. Area under the curve extrapolated (AUC%extrap) of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

  3. Terminal half life of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

  4. Time to peak concentration (Tmax) of alprazolam

    Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2011
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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