Study Comparing 2 Different Formulations of Pantoprazole... | NCT00383916

Studies
Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

NCT00383916

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Mar 8, 2007Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

pantoprazole

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 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Oct 2, 2006

First Submission Date that Met QC Criteria

Oct 2, 2006

First Posted Date

Oct 4, 2006Estimated

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 7, 2007

Last Update Posted Date

Mar 8, 2007Estimated

Description Module

Brief Summary

A study comparing 2 different investigational formulations of pantoprazole in healthy adults.

Detailed Description

open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
pantoprazole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.

Secondary Outcomes

Measure	Description	Time Frame
To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Men or women aged 18 to 50 years.
Healthy as determined by the investigator.

Exclusion Criteria

History or active presence of clinically important medical disease.
History of drug or alcohol abuse.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D000077402	Pantoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided