The Development of Oral Nalbuphine Dosage Form

NCT ID: NCT00924079

Last Updated: 2009-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

nalbuphine

Group Type: EXPERIMENTAL

nalbuphine

Intervention Type: DRUG

oral dosage form, 66 mg, single dose

Interventions

nalbuphine

oral dosage form, 66 mg, single dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of anesthsiology of Tri-service General Hospitial

Locations

Tri-Service General Hospitial

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Ho Shung-Tai, MD

Role: primary

painlab@ndmctsgh.edu.tw

886-2-87927125

Other Identifiers

TSGHIRB096-02-010-I

Identifier Type: -

Identifier Source: secondary_id

NAL001

Identifier Type: -

Identifier Source: org_study_id