Bioequivalence Study of Fosinopril Sodium / Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fed Conditions

NCT00778713 | Completed DMC

• 1 other identifier: B035502
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited with that of Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet) in healthy adult subjects under non-fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of Ranbaxy laboratories Limited

Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets

2

ACTIVE COMPARATOR

Monopril ® - HCT 20-12.5 mg tablets by Bristol Meyers Squibb following a single oral dose (1 x 20/12.5 mg tablet)

Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets

Interventions

Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets DRUG

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects should be at least 18 years old
• Female subjects with negative serum pregnancy test
• Subject with no clinically significant abnormal lab values at the pre-entry evaluation
• Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C and HIV screening
• Subject has acceptable ECG
• Subject has no evidence of underlying disease at the pre-entry physical examination
• Subject has agreed to undergo at least a 14 day washout period for prescription drugs prior to the first dosing of the study and throughout the periods of blood sample collection
• Subject has agreed to undergo at least a 7 day washout period for OTC products, herbal medications, etc. prior to the first dosing of the study medication and throughout the periods of blood sample collections
• Subject agrees to abstain from consuming alcohol for at least 48 hours prior to each dosing and throughout the periods when blood samples are being obtained
• Subject agrees to abstain from consuming grapefruit, grapefruit juice, or other foods containing grapefruit for at least 48 hours prior to each dosing and throughout the periods when blood samples are being obtained
• Subject has given a written consent to participate

You may not qualify if:

• Subject has a history of chronic alcohol consumption (during past 2 years) or drug addiction
• Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
• Subject has a history of allergic responses to the class of drug being tests
• Subject has donated any blood and/ or plasma within the last thirty (30) days prior to the first dosing of the study
• Subject has taken any investigational drug within thirty (30) days prior to the first dosing of the study
• Female subjects who are pregnant, breast feeding, or likely to be come pregnant during the study. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (eg condom, IUD) of contraception during the course of the study (first dosing until the last blood collection)
• Female subjects who have used implanted or injected hormonal contraceptives (except Lunelle ® Monthly Injection) anytime during the 6 months prior to study dosing, Lunelle ® Monthly Injection anytime during the 45 days prior to the study dosing, or used oral hormonal contraceptives within 14 days before dosing.
• Subject with the inability to read and/ or sign the consent form

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Gateway Medical Research Inc

Saint Charles, Missouri, 63301, United States

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Interventions

Fosinopril; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Phosphinic Acids; Organophosphorus Compounds; Organic Chemicals; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: March 1, 2003
• Primary Completion: March 1, 2003
• Study Completion: April 1, 2003
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

US (1)