Clinical Pharmacokinetic study of Naloxone Hydrochloride film

Phase 1

• Conditions: healthy people

• Registration Number: JPRN-jRCTs041220104
• Lead Sponsor: Ryuji Hayashi

Brief Summary

In this clinical trial, we examined effects of intraoral films of naloxone hydrochloride with 3 doses (low dose of 0.56mg/body, middle dose of 2.2mg/body and high dose of 8.9mg/body) in six healthy subjects. Then, plasma concentration analysis and pharmacokinetics analysis were performed. Dose-dependency was observed by blood concentration and AUC. Tmax, T1/2, and MRT were respectively almost comparable.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-14
• Study Completion: 2023-02-22
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1) healthy adult whose age is 20-50 years old, male or female Japanese
2) body weight is 45-75 kilo grams and BMI is 18.5-25
3) participant who can understand and comply the study plan and give the informed concent in writing with his or her self-judgement

Exclusion Criteria

1) anybody who has the history of malignant disease
2) anybody who has certain chronic disease such as heart disease, liver injury, renal dysfunction, cerebrovascular disease, collagen disease, diabetic mellitus, dyslipidemia, hypertension or others
3) anybody who has daily medicine (including herbal medicine)
4) anybody whose serum creatin is equal or more than 1.5 mg/dL
5) anybody whose serum asparagine acid aminotransferase or alanine aminotransferase is equal or more than twice for institutional normal range
6) anybody whose blood hemoglobin is less than 10 g/dL
7) anybody who needs medicine because of abnormal value of screening test
8) anybody who has allergy history for Naloxone
9) anybody who has severe allergic history for any drug
10) anybody who is pregnant, who is lactating, or who may become pregnant during this clinical trial.
11) anybody who is positive for serum test of HBsAg, HCVAb, HIVAg or HIVAb
12) anybody who is considered to be inappropriate for this study by the principal investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharumacokinetic parameters (Tmax, Cmax, AUC, T1/2, MRT) in each dose