- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03826316
Pharmacokinetics of Nalbuphine Injection
January 30, 2019 updated by: Yung Shin Pharm. Ind. Co., Ltd.
A Study to Evaluate Pharmacokinetics of Nalbuphine Hydrochloride (10 mg/mL) After a Single Intravenous Administration in Healthy Volunteers Under Fasting Conditions
A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single intravenous administration in healthy volunteers under fasting conditions
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan
- Taichung Veterans General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult male subjects between 20-45 years of age.
Body weight within 80-120% of ideal body weight.
* Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects
Acceptable medical history and physical examination including:
- no particular clinically significant abnormalities in chest x-ray and electrocardiogram results within six months prior to study drug dosing.
- no particular clinical significance in general disease history within two months prior to study drug dosing.
- Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes Serum Glutamic Oxaloacetic Transaminase (SGOT, same as AST), Serum Glutamic Pyruvic Transaminase (SGPT, same as ALT), Gamma-Glutamyl-Transpeptidase (γ-GT), alkaline phosphatase, total bilirubin, albumin, glucose, Blood Urea Nitrogen(BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
- Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
- Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to study drug dosing, which includes power of hydrogen (pH), blood, glucose, ketones, bilirubin and protein.
- Male subjects willing to use a condom during any sexual contact with females of reproductive potential for up to 10 weeks after study drug dosing.
- Have signed the written informed consent to participate in the study.
Exclusion Criteria:
- A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the investigator).
- A clinically significant illness or surgery within four weeks prior to dosing (as determined by the investigator).
- History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- Known or suspected history of drug abuse within lifetime as judged by the investigator.
- History of alcohol addiction or abuse within last five years as judged by the investigator.
- History of allergic response(s) to nalbuphine hydrochloride or any other related drugs.
- Evidence of chronic or acute infectious disease.
- Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- Female subjects demonstrating a positive pregnancy screen prior to the study.
- Female subjects who are currently breastfeeding.
- Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
- Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to dosing.
- Use of any investigational drug within four weeks prior to dosing.
- Donating more than 250 milliliter (mL) of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing.
- Any other medical reason as determined by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mutonpain Injection 10 mg/ml
|
Pharmacokinetic study under fasting conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration (AUC)
Time Frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Peak Drug Concentration (Cmax)
Time Frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Elimiation half-life (T1/2)
Time Frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
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Area under the (first) moment plasma concentration-time curve (AUMC)
Time Frame: Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Plasma sample: 0, 0.5, 5, 10, 15, 20, 30, 45 minutes, 1, 2, 4, 6, 8, 10 and 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: Adverse event reporting will up to 10 weeks.
|
Adverse event reporting will up to 10 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2018
Primary Completion (ACTUAL)
November 22, 2018
Study Completion (ACTUAL)
January 15, 2019
Study Registration Dates
First Submitted
January 27, 2019
First Submitted That Met QC Criteria
January 30, 2019
First Posted (ACTUAL)
February 1, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YSP-RJH3002-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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