CompletedPhase 1

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

Singapore16 participantsStarted 2011-05

Plain-language summary

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

Who can participate

Age range20 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

Peak plasma conc (Cmax) of alprazolam

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

Trial details

NCT IDNCT01330472

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Healthy Subjects trials