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Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg

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ClinicalTrials.gov Identifier: NCT00649688
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Mylan Pharmaceuticals

Brief Summary:
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 fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg Drug: Lopressor HCT® Tablets 100/50 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets (100/50 mg; Mylan) and Lopressor HCT® Tablets (100/50 mg; Novartis) in Healthy Volunteers
Study Start Date : January 2003
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003


Arm Intervention/treatment
Experimental: 1
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
Drug: Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
100/50mg, single dose fasting

Active Comparator: 2
Lopressor HCT® Tablets 100/50 mg
Drug: Lopressor HCT® Tablets 100/50 mg
100/50mg, single dose fasting




Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: within 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (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 man and 48 kg (106 lbs) for women and 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, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, 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 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 chronic disease and/or hepatitis.
    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649688


Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute Ltd.

Additional Information:
Responsible Party: Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00649688     History of Changes
Other Study ID Numbers: METZ-0292
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Hydrochlorothiazide
Metoprolol
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents