healthy people
Conditions
Interventions
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
Sponsors
Ryuji Hayashi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharumacokinetic parameters (Tmax, Cmax, AUC, T1/2, MRT) in each dose | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 . | — |
Contacts
Public ContactOkabe Keisuke
Toyama University Hospital
Outcome results
None listed