Bioequivalence Study of Ciprofloxacin in Healthy Adult Subjects Under Fasting Condition

NCT05532267 | Completed Phase 1

• 1 other identifier: CIP-B-20-030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Bioequivalence; Randomized; Crossover; Ciprofloxacin

Outcome Measures

Primary Outcomes (3)

• Maximum blood concentration (Cmax)

  Cmax is observed as the maximum of ciprofloxacin peak concentration

  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

  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

  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 (3)

• Maximum time (Tmax)

  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)

  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).

  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

Study Arms (2)

Test Product (T)

EXPERIMENTAL

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

Reference Product (R)

ACTIVE COMPARATOR

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

Interventions

Ciprofloxacin 750 mg DRUG

an immediate release film-coated tablet containing 750 mg Ciprofloxacin

Also known as: Test product (T)

Test Product (T)

Ciproxin 750 mg DRUG

an immediate release film-coated tablet containing 750 mg Ciprofloxacin

Also known as: Reference product (R)

Reference Product (R)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future Research Center (FRC)

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hala Masoud, PhD

  Future Research Center (FRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FRC Technical Director & CEO

Model Details: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: November 4, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months following article publication and no end date
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to \<hala.fut.masoud@gmail.com\> To gain access.

Locations

EG (1)