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

JRCT ID: jRCTs031220436

Registered date:04/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 04/11/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): The study will conduct on healthy Japanese adult males (20-45 years old). The study will measure and compare blood levels of ciprofloxacin in three phases: ciprofloxacin tablets taken with water, ciprofloxacin tablets taken with Thickened water, and ciprofloxacin tablets crushed taken with Thickened water. There will be a 6-day withdrawal period as a washout period for ciprofloxacin, and the effects of taking the drug with Thickened water will evaluate in an open-label study. All studies will conduct on the same study subjects.

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters of Ciprofloxacin in Primary Outcome serum (AUC0-24,Cmax)
• Secondary Outcome: Pharmacokinetic parameters of Ciprofloxacin in Secondary Outcome serum (t1/2,tmax)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hida Noriko