HealthyNALNCT00924079
The Development of Oral Nalbuphine Dosage Form
A study testing nalbuphine in people with Healthy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- nalbuphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospitial
Taipei, 11490
Ho Shung-Tai, MD, 886-2-87927125, painlab@ndmctsgh.edu.tw
Ho Shung-Tai, MD
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- nalbuphine
- Keywords
- Analysis of plasma concentration of nalbuphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphineDrug
oral dosage form, 66 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| nalbuphine | Experimental | Not described Receives: Drug: nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924079
- Sponsor's protocol ID
- NAL001
- Other IDs
- TSGHIRB096-02-010-I
- Acronym
- NAL
- Status last verified
- Jun 2009
- First submitted
- 17 Jun 2009
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT00924079
- Acronym / sponsor ID
- NAL / NAL001
- Conditions
- Healthy
- Keywords
- Analysis of plasma concentration of nalbuphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2009 (estimated)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nalbuphine | Experimental | Drug: nalbuphine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- 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:
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nalbuphineoral dosage form, 66 mg, single dose | Drug | nalbuphine |
Primary outcome
Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nalbuphine in people with Healthy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.