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

JRCT ID: jRCTs031240073

Registered date:10/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 10/05/2024
• Target sample size: 6
• Study type: Interventional

Intervention(s)

The study will be conducted on healthy Japanese adult males (20-45 years old).
The study will measure and compare blood levels of carbamazepine in three phases: carbamazepine tablets taken with water, carbamazepine tablets taken with Thickened water, and carbamazepine fine granules taken with Thickened water. There will be a 14-day withdrawal period as a washout period for carbamazepine, and the effects of taking the drug with Thickened water will be evaluated in an open-label study. All studies will be conducted on the same study subjects.

Outcome(s)

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

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) Persons with hypothyroidism or a history of such disorders.
3) Persons with epilepsy or other convulsive disorders or a history of such disorders.
4) Persons with dysuria or ocular hypertension, etc.
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 wish their partner to become pregnant during the study period.
9) Persons with a history of drug eruptions caused by carbamazepine in the individual or their family.
10)Those who are within three months of participating in another clinical research study.
11) Any other person who judges by the investigator to be ineligible for the study.

Related Information

• Primary Sponsor: Hida Noriko