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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00649688

Healthy

COMPLETED PHASE1

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

NCT00649038

Healthy

COMPLETED PHASE1

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

NCT00547300

Hypertension

TERMINATED PHASE3

Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients

NCT03946514

Hypertension

COMPLETED PHASE4

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

NCT00953680

Hypertension

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg

Group Type EXPERIMENTAL

Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg

Intervention Type DRUG

100/50mg, single dose fed

2

Lopressor HCT® Tablets 100/50 mg

Group Type ACTIVE_COMPARATOR

Lopressor HCT® Tablets 100/50 mg

Intervention Type DRUG

100/50mg, single dose fed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg

100/50mg, single dose fed

Intervention Type DRUG

Lopressor HCT® Tablets 100/50 mg

100/50mg, single dose fed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes