Status:
UNKNOWN
The Development of Oral Nalbuphine Dosage Form
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Healthy
Eligibility:
All Genders
20-40 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.
Eligibility Criteria
Inclusion
- Normal healthy adult subjects between 20-40 years of age.
- Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7
- Acceptable medical history and physical examination including:
- Normal chest X-ray and ECG results within six months prior to Period I dosing.
- No particular clinical significance in general disease history within two months prior to Period I dosing.
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:
- AST (SGOT)
- ALT (SGPT)
- Gama-GT
- alkaline phosphatase
- total bilirubin
- albumin
- glucose
- BUN
- uric acid
- creatinine
- total cholesterol
- triglyceride(TG)
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
- Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
- Signed the written informed consent to participate in this study.
Exclusion
- Recent history of drug or alcohol addiction or abuse.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to nalbuphine or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious diseases.
- Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
- Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
- Receiving any investigational drug within one month prior to Period I dosing.
- Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
- Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
- Any other medical reason as determined by the clinical investigator.
- Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00924079
Start Date
September 1 2008
Last Update
June 19 2009
Active Locations (1)
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1
Tri-Service General Hospitial
Taipei, Taiwan, 11490