Bioequivalence study of ciprofloxacin 500 mg tablets

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2021
INTERVENTION: Intervention 1: Intervention group: Oral administration of a single 500 mg dose of ciprofloxacin (1 tablet) manufactured by Sanamed to healthy volunteers under fasting condition in the morning of the experiment day. Intervention 2: Intervention group: Oral administration of a single 500 mg dose of Ciproxin (1 tablet) manufactured by Bayer to healthy volunteers under fasting condition in the morning of the experiment day. CONDITION: .. PRIMARY OUTCOME: Area under plasma concentration‐time curve. Timepoint: At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high‐performance liquid chromatography. Drug plasma concentration. Timepoint: At time zero and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high‐performance liquid chromatography. SECONDARY OUTCOME: Plasma half‐life. Timepoint: From the terminal 8 hours of plasma concentration‐time profile. Method of measurement: Blood sampling and drug analysis by high‐performance liquid chromatography method. INCLUSION CRITERIA: 18‐55 years of age. The subject is able and willing to provide signed informed consent. The subject is available for the entire study period. Willing to adhere to protocol requirements as evidenced by written informed consent. The subject has a stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
Epistemonikos ID: bc6398205d9c2e430cff994ef2a122518afbd2aa
First added on: Sep 25, 2021