Status and phase
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Treatments
About
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age: 18 years and older.
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must have negative serum beta human chorionic gonadotropin (β-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 weekends, serum should be collected within 24 hours prior to dosing of each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
Women must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
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. Males must also use a spermicide containing barrier method of contraception to prevent the pregnancy of their sexual partners. These stipulations 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, hepatitis C and HIV tests, 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 ciprofloxacin or any other quinolone (e.g., ofloxacin, levofloxacin, or lomefloxacin) or any 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
36 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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