Bioequivalence Study of Ciprofloxacin in Patients with Impaired Renal Function and Bacterial Infection

The primary objective of this study is to assess the **bioequivalence** of ciprofloxacin in patients with impaired renal function, specifically those with an estimated glomerular filtration rate (eGFR) of less than 30 ml/min/1.73m². The study compares the drug exposure in the first 24 hours of treatment (AUC0-24) between two groups: patients receiving revised reduced doses of ciprofloxacin (750 mg orally once daily or 600 mg intravenously once daily) and patients with adequate renal function receiving regular doses (500 mg orally twice daily or 400 mg intravenously twice daily). This evaluation is clinically relevant as it aims to ensure that patients with impaired renal function receive an effective and safe dosage of ciprofloxacin, minimizing the risk of adverse effects while maintaining therapeutic efficacy in treating **bacterial infections**.

The clinical trial involves participants diagnosed with **bacterial infection** and aims to assess the bioequivalence of ciprofloxacin in patients with varying renal function. The study population includes both male and female subjects aged 18 years and older. Participants are required to be admitted to general wards of specific hospitals and must provide informed consent. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants are selected based on their treatment with ciprofloxacin, either intravenously or orally, as part of standard care. The study does not specify any particular lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the **bioequivalence** of **ciprofloxacin** in patients with impaired renal function compared to those with adequate renal function. This is a randomized, double-blind, controlled study, categorized as a Phase IV trial. The trial aims to assess whether drug exposure in the first 24 hours of treatment (AUC0-24) is bioequivalent between the two groups. The study is expected to run from August 19, 2020, to December 31, 2026, with participant involvement lasting up to three days, corresponding to the maximum treatment period.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as being treated with ciprofloxacin intravenously or orally as part of standard care, being at least 18 years old, and providing informed consent. Following the screening, participants will be randomized to receive either the test or reference dose of ciprofloxacin. The test group will receive 750 mg orally once daily or 600 mg intravenously once daily, while the reference group will receive 500 mg orally twice daily or 400 mg intravenously twice daily. Follow-up visits will be conducted to monitor drug exposure and ensure adherence to the dosing regimen. The end-of-study visit will conclude the participant's involvement, during which final assessments will be made.

Participants may be subject to early termination from the study if they experience adverse reactions, withdraw consent, or fail to comply with the study protocol. The trial's primary endpoint is the measurement of drug exposure in the first 24 hours of treatment, with no secondary endpoints specified. The study does not involve a pediatric formulation and is not classified as an orphan drug trial. The trial is conducted under standard ethical guidelines, ensuring the safety and well-being of all participants.

The clinical trial involves the administration of **Ciprofloxacin**, an antiinfective agent, to assess its bioequivalence in patients with impaired renal function compared to those with adequate renal function. The experimental medication, **Ciprofloxacin**, is provided in two forms: **ciprofloxacin hydrochloride** and **ciprofloxacin**. The pharmaceutical form is identified as PHF00134MIG. The medication is administered orally, with a maximum daily dose of 1500 mg and a maximum total dose of 4500 mg over a treatment period of up to 3 days. The trial aims to evaluate the bioequivalence of the drug by comparing the area under the curve (AUC) over the first 24 hours of treatment between the two patient groups.

For patients with impaired renal function, the revised dosing regimen includes 750 mg of **Ciprofloxacin** administered orally once daily or 600 mg intravenously once daily. In contrast, patients with adequate renal function receive the standard dosing regimen of 500 mg orally twice daily or 400 mg intravenously twice daily. The study's primary objective is to determine whether the drug exposure, as measured by AUC024, is bioequivalent between the test group (impaired renal function) and the reference group (adequate renal function).

Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the prescribed regimen. The trial does not involve any non-experimental treatments such as placebo or comparator treatments, as the focus is solely on the bioequivalence of the revised dosing of **Ciprofloxacin** in the specified patient populations.

Efficacy in this clinical trial will be assessed by evaluating the **bioequivalence** of ciprofloxacin between two patient groups: those with impaired renal function and those with adequate renal function. The primary endpoint for efficacy assessment is the drug exposure in the first 24 hours of treatment, measured as the area under the concentration-time curve (AUC_0-24). This parameter will be used to determine if the drug exposure is bioequivalent between the test group (patients with impaired renal function receiving revised reduced doses) and the reference group (patients with adequate renal function receiving regular doses).