The Development of Oral Nalbuphine Dosage Form (NAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Tri-Service General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT00924079
First received: June 17, 2009
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention
Healthy
Drug: nalbuphine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nalbuphine Drug: nalbuphine
oral dosage form, 66 mg, single dose

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924079

Locations
Taiwan
Tri-Service General Hospitial Recruiting
Taipei, Taiwan, 11490
Contact: Ho Shung-Tai, MD    886-2-87927125    painlab@ndmctsgh.edu.tw   
Principal Investigator: Ho Shung-Tai, MD         
Sponsors and Collaborators
Tri-Service General Hospital
  More Information

No publications provided

Responsible Party: Ho Shung-Tai/Professor of the department of anesthsiology, Department of anesthsiology of Tri-service General Hospitial
ClinicalTrials.gov Identifier: NCT00924079     History of Changes
Other Study ID Numbers: NAL001, TSGHIRB096-02-010-I
Study First Received: June 17, 2009
Last Updated: June 18, 2009
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Nalbuphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014