A Phase 1 interventional study of Ciprofloxacin 750 mg and Ciproxin 750 mg in Healthy Subjects, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Future University in Egypt · Phase 1, Interventional, and Health services research
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ciprofloxacin 750 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 7 days.
Ciprofloxacin plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subjects were administered a single film-coated tablet of 750 mg Ciprofloxacin with approximately 240 ml water after an overnight fast of 10 hours
Drug: Ciprofloxacin 750 mg
subjects were administered a single film-coated tablet of 750 mg Ciprofloxacin with approximately 240 ml water after an overnight fast of 10 hours
Drug: Ciproxin 750 mg
an immediate release film-coated tablet containing 750 mg Ciprofloxacin
Also known as: Test product (T)
an immediate release film-coated tablet containing 750 mg Ciprofloxacin
Also known as: Reference product (R)
Maximum blood concentration (Cmax)
Cmax is observed as the maximum of ciprofloxacin peak concentration
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
the area under the curve (AUC 0-t)
Cumulative Area Under the ciprofloxacin plasma concentration-time Curve calculated from 0 to time of last quantifiable concentration (t last) using the Trapezoidal method
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
the area under the curve extrapolated to infinity (AUC0-∞)
AUC from Dosing time extrapolated to infinity, based on the last observed concentration
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
Maximum time (Tmax)
Time until Cmax is reached
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
Apparent terminal half-life (t½)
the time required for the ciprofloxacin plasma concentration to decrease by 50% after the pseudo-equilibrium of distribution has been reached
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
Apparent elimination rate constant (Kel).
First-order rate constant associated with the terminal (log-linear) portion of the curve
Time frame: Pre-dose (0) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours after drug administration
Plan to share: Yes — Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Future University in Egypt