Clinical Pharmacokinetic study of Naloxone Hydrochloride film

JRCT ID: jRCTs041220104

Registered date:14/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy people
• Date of first enrollment: 26/12/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Three doses of Naloxone film preparation for oral mucosa will be administered every 7 days. Three kinds of doses, 0.56 mg, 2.2 mg or 8.9 mg each, will be administered in order one by one. Before each drug administration, 14mL of blood sample will be collected. At 5, 10, 20, 30, 40, 60, 120, 240 and 360 min after each drug administration, 5mL of blood samples will be collected.The vital signs (blood pressure, pulse rate) and the condition of oral mucosa where the drug is administered will be checked after 30 min and 360 min blood collection. Pharmacokinetics will be measured at every sample point. The blood test before drug administration includes blood counts and biochemistry.

Outcome(s)

• Primary Outcome: Pharumacokinetic parameters (Tmax, Cmax, AUC, T1/2, MRT) in each dose

Secondary Outcome

(1) safety (symptom, local change of film stuck region, blood pressure, pulse rate, blood examination)
symptom; the coordinaters will ask and record the symptom of the participants after film attaching
local change of film attached region; the nurses check the film attached region and record the findings. The nurses call the doctors if they find some change. The doctors will see the participant, record the findings and take photo of local change.
vital sign; blood pressure, pulse rate will be measured at before film attaching, after 30 and 360 min.
blood test conducted before each film attaching and 7 days after 8.9 mg film attaching;
a. bood count: WBC, RBC, Hb, Ht, Plt
b. biochemistry: TG, T-cho, Glu, AST, ALT, r-GTP, ALP, LDH, CK, T-Bil, TP, Alb, UA, BUN, Cre, Na, Cl, K
(2) Bioavailability
Bioavailability will be calculated with the obtained pharmacokinetics data and the historical data.
(3) Time for dissolution of the naloxone film
Time for dissolution of the naloxone film will be evaluated at each examination. Participants are required to report the dissolution of Naloxone film during the examination by their perceptive. The coordinators will record the time for dissolution. The coordinators will ask participants about film dissolution at 5 and 10 min after film attaching. Participants will be encouraged not to touch the film by tongue unnecessarily.
(4) feeling of film attached
Examiner collects the feeling of attached film from participant at the end of examination (8.9mg film attaching) and record them on report file .

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ryuji Hayashi
• Source(s) of Monetary Support: Cabinet Office