None listed
Conditions
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult aged 19-55 years 2. BMI of 17.5-30.5 kg/m2 and weight = 45 kg 3. No congenital disease, no chronic disease within the past three years, and no abnormal finding in the internal medicine examination 4. Passed the screening tests, including laboratory tests such as hematology, blood chemistry, and urinalysis 5. Signed the Informed Consent Form 6. Can participate in and complete the study
Exclusion criteria
Exclusion criteria: 1. Has a past or current history of a hematological, renal, endocrinological, respiratory, gastrointestinal, urological, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for an asymptomatic seasonal allergy that has not been treated at the time of administration of the investigational drug) 2. Has a past history of a gastrointestinal disease that may affect the drug absorption (e.g., an esophageal disease such as achalasia or esophageal stenosis, or Crohn’s disease) or surgery (except for appendectomy or inguinal hernia repair) 3. Had an alcohol intake of > 210 g/week within six months before the screening [one cup of beer (5%) (250 ml) = 10 g; one cup of soju (20%) (50 ml) = 8 g; and one cup of wine (12%) (125 ml) = 12 g] 4. Participated in another clinical study within two months before this study 5. Has a systolic blood pressure = 140 mmHg and a diastolic blood pressure = 90 mmHg 6. Had alcohol or drug abuse within one year before the screening 7. Received drugs known to significantly induce or suppress CYPs(cytochromes P450) within one month before this study 8. Smokes 20 cigarettes or more a day 9. Received prescription or over the counter(OTC) drugs within 10 days before this study 10. Donated blood within two months before this study (including apheresis) 11. Has a modest or chronic medical or psychiatric disease and abnormal laboratory test results that may compromise the interpretation of the results of this study 12. Pregnant or lactating 13. Has intolerance or hypersensitivity to the ingredients of fentanyl 14. Cannot tolerate opioids 15. Cannot comply with the lifestyle guidelines described in the study protocol 16. Considered by the investigator capable of participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, Cmax of acupan (nefopam hydrochloride);AUCinf, Tmax, t1/2, CL/F, Vd/F of acupan (nefopam hydrochloride) | — |
Secondary
| Measure | Time frame |
|---|---|
| vital sign;the evaluate adverse event;physical examination;lab test | — |
Countries
Korea, Republic of
Contacts
Public ContactLEE YOUNG
Chonbuk National University Hospital
Outcome results
None listed