NCT00913341

Brief Summary

To demonstrate the relative bioavailability of Alprazolam tablets, 1 mg.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 anxiety

Timeline
Completed

Started Nov 1991

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1991

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1991

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1991

Completed
17.6 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

March 28, 2017

Status Verified

June 1, 2009

Enrollment Period

Same day

First QC Date

June 2, 2009

Last Update Submit

March 27, 2017

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    13 days

Study Arms (2)

1

EXPERIMENTAL

Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)

Drug: Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)

2

ACTIVE COMPARATOR

Alprazolam Tablets, 1 mg (The Upjohn Company)

Drug: Alprazolam Tablets, 1 mg (The Upjohn Company)

Interventions

Alprazolam Tablets, 1 mg (Geneva Pharmaceuticals)DRUG
1
Alprazolam Tablets, 1 mg (The Upjohn Company)DRUG
2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Niloufar Guiv, M.D.

    PharmaKinetics Laboratories Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

November 1, 1991

Primary Completion

November 1, 1991

Study Completion

November 1, 1991

Last Updated

March 28, 2017

Record last verified: 2009-06