A comparative pharmacokinetic study of ciprofloxacin when taken with water and thickened water in healthy adult males.

Not Applicable

• Conditions: Healthy Adults

• Registration Number: JPRN-jRCTs031220436
• Lead Sponsor: Hida Noriko

Brief Summary

Ciprofloxacin tablets may affect pharmacokinetics when taken in tablet form with thickened water.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-04
• Study Completion: 2023-03-17
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1) Age: The applicant must be at least 20 years old and less than 45 years old at the time of obtaining consent.
2) Gender: Male
3) Who have the capacity to give consent, abide by the rules of compliance during participation in the research, and are able to undergo the pre-test specified in the research protocol, and report subjective symptoms, etc.
4) Those who have been judged eligible for participation in this study by the pysician in charge of the research or othewe relevant personnel based on a preliminary examination as stipulated in the research protocol.

Exclusion Criteria

1) Persons with a medical history (drug abuse/dependence, alcohol abuse/dependence, heart, liver, kidney, lung, eye, or blood disease, etc.) that may affect the evaluation and safety of this study.
2) Themselves, whose parents, or siblings are prone to allergic symptoms such as bronchial asthma, rash, urticaria, etc.
3) Persons with epilepsy or other convulsive disorders or a history of such disorders
4) Persons with a history of aortic aneurysm or aortic dissection, family history, or risk factors (congenital connective tissue abnormalities such as Marfan syndrome).
5) Persons taking medications (including supplements and dietary supplements) that may affect the evaluation and safety of this study.
6) Persons with a history of drug allergy.
7) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol during the study period)
8) Those who are within three months of participating in another clinical research study
9) Any other person who judges by the investigator to be ineligible for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Ciprofloxacin in Primary Outcome serum (AUC0-24,Cmax)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Ciprofloxacin in Secondary Outcome serum (t1/2,tmax)