Bioequivalence of Acetaminophen Tablets and Acetaminophen Jelly in Healthy Adult Males

JRCT ID: jRCTs031220122

Registered date:09/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 02/08/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): The study will be conducted in healthy Japanese adult males (20-45 years old), and the dosing study will be conducted as a two-drug, two-phase dosing study, and blood levels will be measured for comparison. There will be a 6-day withdrawal period as a washout period for acetaminophen, and the effects of different acetaminophen dosage formswill be evaluated in an open-label study. All studies will be conducted with the same study subjects.

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters of acetaminophen in Primary Outcome(s) plasma (AUC0-8, Cmax)

Secondary Outcome

1. Differences in subjective evaluation of ease of taking (100 mm VAS)
2. All adverse events up to 8 hours after taking the study drug

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 physician in charge of the research or other 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) Those with a history or current history of peptic ulcer
3) Those with bleeding tendency
4) Those with aspirin asthma
5) Are taking medications (including dietary supplements and dietary supplements) that may affect the evaluation and safety of this study.
6) Persons who are using or may use any medication (including OTC) containing acetaminophen
7) Persons with a history of drug allergy
8) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol during the study period)
9) Those who are within 3 months of participating in another clinical research study
10) Any other person who is judged by the investigator to be ineligible for the study.

Related Information

• Primary Sponsor: Hida Noriko
• Secondary Sponsor: Momo Kenji