Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of Nalbuphine Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826316
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Taichung Veterans General Hospital
Information provided by (Responsible Party):
Yung Shin Pharm. Ind. Co., Ltd.

Brief Summary:
A study to evaluate pharmacokinetics of nalbuphine hydrochloride (10 mg/mL) after a single intravenous administration in healthy volunteers under fasting conditions

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Nalbuphine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate Pharmacokinetics of Nalbuphine Hydrochloride (10 mg/mL) After a Single Intravenous Administration in Healthy Volunteers Under Fasting Conditions
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : November 22, 2018
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mutonpain Injection 10 mg/ml Drug: Nalbuphine
Pharmacokinetic study under fasting conditions




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Adverse event reporting will up to 10 weeks. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male subjects between 20-45 years of age.
  2. Body weight within 80-120% of ideal body weight.

    * Ideal body weight (kg) = [height (cm) - 80] *0.7 for male subjects

  3. 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.
  4. 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).
  5. 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.
  6. 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.
  7. 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.
  8. Have signed the written informed consent to participate in the study.

Exclusion Criteria:

  1. 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).
  2. A clinically significant illness or surgery within four weeks prior to dosing (as determined by the investigator).
  3. 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.
  4. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
  5. Known or suspected history of drug abuse within lifetime as judged by the investigator.
  6. History of alcohol addiction or abuse within last five years as judged by the investigator.
  7. History of allergic response(s) to nalbuphine hydrochloride or any other related drugs.
  8. Evidence of chronic or acute infectious disease.
  9. Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
  10. Female subjects demonstrating a positive pregnancy screen prior to the study.
  11. Female subjects who are currently breastfeeding.
  12. 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.
  13. Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to dosing.
  14. Use of any investigational drug within four weeks prior to dosing.
  15. 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.
  16. Any other medical reason as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826316


Locations
Layout table for location information
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Sponsors and Collaborators
Yung Shin Pharm. Ind. Co., Ltd.
Taichung Veterans General Hospital
Layout table for additonal information
Responsible Party: Yung Shin Pharm. Ind. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03826316    
Other Study ID Numbers: YSP-RJH3002-01
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung Shin Pharm. Ind. Co., Ltd.:
Pharmacokinetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents