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

NCT01330472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-01-28

No results posted yet for this study

Summary

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

Conditions

  • Healthy Subjects

Interventions

DRUG

Xanax XR tablets 3 mg (sourced from Caugus)

Tablets, 3 mg, single dose

DRUG

Xanax XR tablets 3 mg (sourced from Barceloneta)

Tablets, 3 mg, single dose

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330472 on ClinicalTrials.gov