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

• Sponsor: Ranbaxy Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00777972
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 33.4

Study Details

Study Description

Brief Summary

The objective of this study was to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by 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 fasting conditions

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets	N/A

Detailed Description

This study was a single dose, randomized, two period, two treatment, two sequence crossover study design was used to evaluate the relative bioavailability of Fosinopril sodium and hydrochlorothiazide tablet products when dose (1 x 20-12.5 mg) under fasting conditions. The two periods of the study were separated by a washout period of at least a week.

A total of 36 healthy adult subjects were enrolled in the study. Of all the subjects 34 subjects (21 males and 13 females) completed the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/12.5 mg Tablets Under Fasting Conditions
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Mar 1, 2003
• Actual Study Completion Date: Apr 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited	Drug: Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets
Active Comparator: 2 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

Outcome Measures

Primary Outcome Measures

1. Bioequivalence []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subjects should be at least 18 years old

2. Female subjects with negative serum pregnancy test

3. Subject with no clinically significant abnormal lab values at the pre-entry evaluation

4. Subjects with negative or non-reactive urine drug of abuse, hepatitis B, hepatitis C and HIV screening

5. Subject has acceptable ECG

6. Subject has no evidence of underlying disease at the pre-entry physical examination

7. 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

8. 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

9. 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

10. 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

11. Subject has given a written consent to participate

Exclusion Criteria:

1. Subject has a history of chronic alcohol consumption (during past 2 years) or drug addiction

2. Subject has a history of serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma

3. Subject has a history of allergic responses to the class of drug being tested.

4. Subject has donated any blood and/ or plasma within the last thirty (30) days prior to the first dosing of the study

5. Subject has taken any investigational drug within thirty (30) days prior to the first dosing of the study

6. 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)

7. 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.

8. Subject with the inability to read and/ or sign the consent form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gateway Medical Research Inc	St Charles	Missouri	United States	63301

Sponsors and Collaborators

• Ranbaxy Laboratories Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00777972
• Other Study ID Numbers: B035501
• First Posted: Oct 23, 2008
• Last Update Posted: Oct 23, 2008
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: Bioequivalence Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets fasting conditions
• Additional relevant MeSH terms: Disease; Hydrochlorothiazide; Fosinopril

Study Results

No Results Posted as of Oct 23, 2008