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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01330472
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
1
Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Xanax XR tablets 3 mg (sourced from Caugus)
  • Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Xanax XR tablets 3 mg (sourced from Caugus)

Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)

Drug: Xanax XR tablets 3 mg (sourced from Caugus)
Tablets, 3 mg, single dose
Experimental: Xanax XR tablets 3 mg (sourced from Barceloneta),

Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)

Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)
Tablets, 3 mg, single dose

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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 Outcome Measures

  1. 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]

  2. 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]

  3. Terminal half life of alprazolam [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 [Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Singapore Singapore 188770

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01330472
Other Study ID Numbers:
  • A6131025
First Posted:
Apr 7, 2011
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Alprazolam
Xanax
Bioequivalence
Panic disorder with or without agoraphobia.
Additional relevant MeSH terms:
Alprazolam

Study Results

No Results Posted as of Jan 28, 2021