Bioequivalence of a New Sublingual and a Reference Alpraz... | NCT01027689

Studies
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

NCT01027689

Sponsor

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

Status

Withdrawn

Last Update Posted

Jan 28, 2021Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Healthy

Interventions

alprazolam commercial immediate release oral tablet
alprazolam test sublingual tablet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 7, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alprazolam commercial immediate release oral tablet	Active Comparator		Drug: alprazolam commercial immediate release oral tablet
Alprazolam test sublingual tablet	Experimental		Drug: alprazolam test sublingual tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alprazolam commercial immediate release oral tablet	Drug	1 mg tablet, single dose	Alprazolam commercial immediate release oral tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)		11 days

Secondary Outcomes

Measure	Description	Time Frame
Alprazolam time of maximum concentration (Tmax) and half life		11 days
Adverse events, clinical laboratory tests, vital signs		11 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female subjects
BMI 17.5 - 30.5
Must provide informed consent

Exclusion Criteria:

Clinically significant disease
Narrow angle glaucoma
Positive drug screen

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring