Bioequivalence Study Between Two Oral Formulations of Fam... | NCT00802828

Studies
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions

NCT00802828

Sponsor

Perrigo Company

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

44Actual

Phase

Phase 1

Conditions

Bioavailability

Interventions

Famotidine Tablets, 40 mg

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jun 2004Actual

Completion Date

Not provided

First Submitted Date

Dec 3, 2008

First Submission Date that Met QC Criteria

Dec 4, 2008

First Posted Date

Dec 5, 2008Estimated

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

Mar 15, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Description Module

Brief Summary

Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.

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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Product	Active Comparator		Drug: Famotidine Tablets, 40 mg
Reference Product	Active Comparator		Drug: Famotidine Tablets, 40 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Famotidine Tablets, 40 mg	Drug		Reference Product Test Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy men or women 18 years of age or older
body mass index below 30.0 kg/m2
willing to participate and sin a copy of the informed consent form

Exclusion Criteria:

recent history of drug or alcohol addiction or abuse
pregnant or lactating women
history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
recipient of any drugs as part of a research study within 30 days prior to study dosing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015738	Famotidine

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided