The Development of Oral Nalbuphine Dosage Form (NAL)

Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: nalbuphine

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11490
    • Recruiting
    • Tri-Service General Hospitial
    • Contact: Ho Shung-Tai, MD; Phone Number: 886-2-87927125; Email: painlab@ndmctsgh.edu.tw
    • Principal Investigator: Ho Shung-Tai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nalbuphine	Drug: nalbuphine; oral dosage form, 66 mg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2	24 hours

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): November 1, 2009
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimate): June 18, 2009

Study Record Updates

• Last Update Posted (Estimate): June 19, 2009
• Last Update Submitted That Met QC Criteria: June 18, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Analysis of plasma concentration of nalbuphine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Nalbuphine
• Other Study ID Numbers: NAL001; TSGHIRB096-02-010-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No