Bioequivalence evaluation of 2 different oral formulations of ciprofloxacin in healthy volunteers. 1998

I Galicia, and J Frias-Iniesta, and A J Carcas, and A Soto, and E Gomez, and E Miranda, and A Fernandez, and C Montuenga
Servicio de Farmacología Clínica, H.U. La Paz, Departamento de Farmacología y Terapeútica, Universidad Autónoma de Madrid, Spain.

A bioequivalence study of 2 oral formulations of 500 mg tablets of ciprofloxacin was carried out in 24 healthy volunteers according to a single dose, two-sequence, crossover randomized design. Blood samples were taken prior to each administration and at 13 points within 32 hours after the dose, and plasma concentrations of ciprofloxacin were determined by HPLC. The pharmacokinetic parameters Cmax and tmax were obtained directly from plasma data, ke was estimated by log-linear regression, and AUC was calculated by the trapezoidal rule. The pharmacokinetic parameters AUC and Cmax were tested for bioequivalence after log-transformation of data, differences of tmax were evaluated nonparametrically. The 90% standard confidence intervals of the mean values for the test/reference ratios were 0.87-0.97 for AUC and 0.91-1.05 for Cmax, within the bioequivalence acceptable range of 0.80-1.25 limits. So, we conclude that both formulations were found bioequivalent and, therefore, interchangeable.

UI MeSH Term Description Entries
D008297 Male Males
D002626 Chemistry, Pharmaceutical Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use. Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D002939 Ciprofloxacin A broad-spectrum antimicrobial carboxyfluoroquinoline. Bay-09867,Ciprinol,Cipro,Ciprofloxacin Hydrochloride,Ciprofloxacin Hydrochloride Anhydrous,Ciprofloxacin Monohydrochloride Monohydrate,Anhydrous, Ciprofloxacin Hydrochloride,Bay 09867,Bay09867,Hydrochloride Anhydrous, Ciprofloxacin,Hydrochloride, Ciprofloxacin,Monohydrate, Ciprofloxacin Monohydrochloride,Monohydrochloride Monohydrate, Ciprofloxacin
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000890 Anti-Infective Agents Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection. Anti-Infective Agent,Anti-Microbial Agent,Antimicrobial Agent,Microbicide,Microbicides,Anti-Microbial Agents,Antiinfective Agents,Antimicrobial Agents,Agent, Anti-Infective,Agent, Anti-Microbial,Agent, Antimicrobial,Agents, Anti-Infective,Agents, Anti-Microbial,Agents, Antiinfective,Agents, Antimicrobial,Anti Infective Agent,Anti Infective Agents,Anti Microbial Agent,Anti Microbial Agents
D001682 Biological Availability The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Availability Equivalency,Bioavailability,Physiologic Availability,Availability, Biologic,Availability, Biological,Availability, Physiologic,Biologic Availability,Availabilities, Biologic,Availabilities, Biological,Availabilities, Physiologic,Availability Equivalencies,Bioavailabilities,Biologic Availabilities,Biological Availabilities,Equivalencies, Availability,Equivalency, Availability,Physiologic Availabilities
D013030 Spain Country located between France on the northeast and Portugal on the west and bordered by the Atlantic Ocean and the Mediterranean Sea. The capital is Madrid. Balearic Islands,Canary Islands
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies

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