Status and phase
Conditions
Treatments
About
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age: 18 years and older.
Sex: Male and non-pregnant, non-lactating female
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.
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:
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.
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).
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
Institutionalized subjects will not be used.
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Allergy or hypersensitivity to metoprolol, hydrochlorothiazide, any of the inactive ingredients, or other related products.
History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal