The Development of Oral Nalbuphine Dosage Form (NAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924079
Recruitment Status : Unknown
Verified June 2009 by Tri-Service General Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : June 19, 2009
Information provided by:
Tri-Service General Hospital

Brief Summary:
The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: nalbuphine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects
Study Start Date : September 2008
Estimated Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nalbuphine Drug: nalbuphine
oral dosage form, 66 mg, single dose

Primary Outcome Measures :
  1. Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2 [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924079

Tri-Service General Hospitial Recruiting
Taipei, Taiwan, 11490
Contact: Ho Shung-Tai, MD    886-2-87927125   
Principal Investigator: Ho Shung-Tai, MD         
Sponsors and Collaborators
Tri-Service General Hospital

Responsible Party: Ho Shung-Tai/Professor of the department of anesthsiology, Department of anesthsiology of Tri-service General Hospitial Identifier: NCT00924079     History of Changes
Other Study ID Numbers: NAL001
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009

Keywords provided by Tri-Service General Hospital:
Analysis of plasma concentration of nalbuphine

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists