Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg

Drug: Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg

2

ACTIVE COMPARATOR

Lotensin HCT® Tablets 20 mg/25 mg

Drug: Lotensin HCT® Tablets 20 mg/25 mg

Interventions

Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mgDrug

20/25mg, single dose fed

Lotensin HCT® Tablets 20 mg/25 mgDrug

20/25mg, single dose fed

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must have negative serum -human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, serum samples for β-HCG testing may be collected and sent for analysis within 48 hours prior to dosing for both study periods. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

MeSH Terms

Interventions

benazeprilHydrochlorothiazide

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

James Carlson, Pharm. D.
PRACS Institute Ltd.
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 30, 2008

First Posted

April 1, 2008

Study Start

December 2002

Date type not reported

This date has not been verified as actual or estimated.

Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

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

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations