Expired Study
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Fargo, North Dakota 58104


Purpose:

The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg) dose administration under fed conditions.


Criteria:

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior to dosing of each study period. If dosing is scheduled for a Sunday or Monday, the Beta-HCG pregnancy test should be given within 48 hours prior to dosing for that study period. An additional Beta-HCG pregnancy test will be performed upon completion of the study. 2. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following: 1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or 2. barrier methods containing or used in conjunction with a spermicidal agent, or 3. postmenopausal or surgical sterility accompanied with a documented postmenopausal course of at least one year (tubal ligation, oophorectomy or hysterectomy). 3. During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form. 3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication. Exclusion Criteria: 1. Institutionalized subjects will not be used. 2. Social Habits: 1. Use of any tobacco products. 2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. 3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication. 4. Any recent, significant change in dietary or exercise habits. 3. Medications: 1. Use of any medication within the 14 days prior to the initial dose of study medication initiated at least 3 months prior to study medication dosing. (This includes oral contraceptives and hormonal replacement therapy.) 2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication initiated at least 3 months prior to study medication dosing. (This includes oral contraceptives and hormonal replacement therapy.) 4. Diseases: 1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease. 2. History of drug and/or alcohol abuse. 3. Acute illness at the time of either the pre-study medical evaluation or dosing. 5. Abnormal and clinically significant laboratory test results: 1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 2. Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Allergy or hypersensitivity to metoprolol, hydrochlorothiazide, any of the inactive ingredients, or other related products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.


Study is Available At:


Original ID:

METZ-0293


NCT ID:

NCT00649233


Secondary ID:


Study Acronym:


Brief Title:

Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg


Official Title:

Single-Dose Food In Vivo Bioequivalence Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets (100/50 mg; Mylan) to Lopressor HCT® Tablets (100/50 mg; Novartis) in Healthy Volunteers


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mylan Pharmaceuticals


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:James D Carlson, Pharm. D.
Principal Investigator
PRACS Institute Ltd.

Study Dates

Start Date:January 2003
Completion Date:February 2003
Completion Type:Actual
Primary Completion Date:February 2003
Primary Completion Type:Actual
Verification Date:March 2008
Last Changed Date:March 31, 2008
First Received Date:March 30, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bioequivalence
Time Frame:within 30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Metoprolol Tartrate/Hydrochlorothiazide Tablets 10
Description:100/50mg, single dose fed
Arm Name:1
Intervention Type:Drug
Name:Lopressor HCT® Tablets 100/50 mg
Description:100/50mg, single dose fed
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
Study Arm Type:Active Comparator
Arm Name:2
Description:Lopressor HCT® Tablets 100/50 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Mylan Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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