Clinical trial NCT05532267: Bioequivalence Study of Ciprofloxacin in Healthy Adult Subjects Under Fasting Condition
Official title: A Randomized, Single Oral Dose, Two-way Crossover, Open-label, Laboratory Blind, Bioequivalence Study Comparing Ciprofloxacin From Two Different Drug Products After Oral Administration to Healthy Adult Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Bioequivalence
Randomized
Crossover
Ciprofloxacin
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Written informed consent is obtained for study.
* Age 18 - 55 years,
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study

Primary outcomes:
measure: Maximum blood concentration (Cmax)
timeFrame: 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
measure: the area under the curve (AUC 0-t)
timeFrame: 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
measure: the area under the curve extrapolated to infinity (AUC0-∞)
timeFrame: 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
Secondary outcomes:
measure: Maximum time (Tmax)
timeFrame: 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
measure: Apparent terminal half-life (t½)
timeFrame: 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
measure: Apparent elimination rate constant (Kel).
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future Research Center (FRC)
state: New Cairo
Study officials:
affiliation: Future Research Center (FRC)
name: Hala Masoud, PhD
role: PRINCIPAL_INVESTIGATOR
References: