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

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

6

The study was initiated with six men as research subjects. They were 28.5 plus or minus 8.5 years old, 172.4 plus or minus 4.8 cm tall and 64.7 plus or minus 4.8 kg in weight (mean plus or minus standard deviation).

The study was conducted as follows, with a washout period of at least six days between each period Period 1: ciprofloxacin tablets with water Period 2: ciprofloxacin tablets with thickened water Period 3: ciprofloxacin tablets (crushed) with Thickened water There were no dropouts throughout the entire period.

In this study, no disease was observed after administration of the study drug. In addition, no abnormalities were observed in clinically relevant or subjective symptoms after administration of the study drug. Based on the above, the study drug judged safety to be satisfactory.

(1) Primary endpoint: AUC0-24 Period 1: 4895.93 plus-minus 140.70 nano-gram-h / mL Period 2: 3928.93 plus-minus 672.05 nano-gram-h / mL Period 3: 4710.85 plus-minus 257.97 nano-gram-h / mL Cmax Period 1: 1322.83 plus-minus 130.06 nano-gram / mL Period 2: 842.08 plus-minus 193.35 nano-gram / mL Period 3: 1172.30 plus-minus 138.24 nano-gram / mL Two-sided 90% confidence intervals and two-sided 80% confidence intervals for the difference between the means of AUC0-24 and Cmax were calculated for periods 2 and 3, respectively, compared to period 1. AUC0-24 when the two-sided 90% confidence interval fell between -30% and 30%, Cmax when the two-sided 80% confidence interval fell between -40% and 40% judged for equivalence. The two-sided 90% confidence intervals for the difference in mean the two-sided 90% confidence intervals for the difference in mean AUC0-24 ranged from -0.42 to 0.03 in period 2 and from -0.26 to 0.19 in period 3 compared with period 1. Therefore, it concluded that the AUC0-24 values were not equivalent in Period 2 compared with Period 1 but were in Period 3. The two-sided 80% confidence intervals for the difference in mean Cmax ranged from -0.57 to -0.16 in Period 2 and from -0.32 to 0.09 in Period 3 compared with Period 1. Therefore, it concluded that the Cmax values were not equivalent in Period 2 compared with Period 1 but were in Period 3. (2) Secondary endpoints: The mean pharmacokinetic parameters (t1/2, tmax) of ciprofloxacin in plasma were as follows t1/2 Period 1: 4.95 plus-minus 0.16 hr. Period 2: 4.70 plus-minus 0.17 hr. p = 0.15 (relative to period 1) Period 3: 5.02 plus-minus 0.12 hr. p = 0.68 (relative to period 1) Tmax Period 1: 0.75 plus-minus 0.11 hr. Period 2: 1.42 plus-minus 0.54 hr. p = 0.22 (relative to period 1) Period 3: 0.83 plus-minus 0.17 hr. p = 0.87 (relative to period 1) No significant differences were found for both t1/2 and tmax, but this time the results were interpreted as the results of an exploratory analysis. All adverse events up to 24 hours after taking the study drug: no safety issues observed for all subjects.

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

Dec. 31, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031220436

Hida Noriko

Clinical Research Institute for Clinical Pharmacology and Therapeutics Showa University

Kitakarasuyama, Setagaya-ku, Tokyo

n.hida@pharm.showa-u.ac.jp

Taki Iori

Showa University

Kitakarasuyama, Setagaya-ku, Tokyo

+81-3-3300-9368

takemoto@pharm.showa-u.ac.jp

Complete

Nov. 04, 2022

Interventional

non-randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

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.

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.

Male

Healthy Adults

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.

Ciprofloxacin

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

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

+81-3-3784-8129

Oct. 28, 2022

none