Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

Single dose crossover BE study

Outcome Measures

Primary Outcomes (3)

Cmax (maximum observed concentration of drug substance in plasma)
26 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
26 hours
AUC0-inf (area under the concentration-time curve from time zero to infinity)
26 hours

Study Arms (2)

Protonix

ACTIVE COMPARATOR

Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)

Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Pantoprazole 40 mg DR Tablet

EXPERIMENTAL

Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Interventions

Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletDrug

Single dose crossover BE study

Pantoprazole 40 mg DR TabletProtonix

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).

Sponsors & Collaborators

Kremers Urban Development Company
Industrylead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Montreal, Quebec, H4R 2N6, Canada

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Gaetano morelli, MD
MDS Pharma Services
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

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

August 10, 2010

First Posted

August 11, 2010

Study Start

September 2005

Date type not reported

This date has not been verified as actual or estimated.

Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Protonix

Pantoprazole 40 mg DR Tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

Protonix

Pantoprazole 40 mg DR Tablet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations