Health Clinical Trial
Official title:
A Bioavailability Study of NALDEBAIN ER Injection and Nalbuphine Injection in Healthy Volunteers.
This is an open-label, sequential 2 cohort, intramuscular injection study in healthy volunteers. The study will enroll approximately 24 healthy volunteers to examine the safety, pharmacokinetics, and bioavailability after intramuscular injection of NALDEBAIN ER Injection and nalbuphine injection.
Each subject in a cohort will be evaluated for study eligibility during the screening period, which is within 28 days prior to receiving the study drug (Day 1). Eligible subjects will be admitted into the study site on Day -1 and will be required to stay in clinical site for 5 (Cohort 1) or 2 nights (Cohort 2) for study procedures in each cohort. Eligible subjects will undergo additional eligibility assessments on Day -1 and those reconfirmed eligible will intramuscularly receive NALDEBAIN ER Injection (Cohort 1) or nalbuphine (Cohort 2) on Day 1. The blood sampling timepoints for Cohort 1 will be at predose, 6, 12, 24, 48, 56, 64, 72, 80, 88, and 96 hours after dosing. Subjects will be discharged after the 96-hour blood sample and return to the clinical site for the sample collection at 120, 168, 216, 288 and 360 hours post dosing. The blood sampling timepoints for Cohort 2 will be predose, 5, 15, and 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose. Subjects will return for a follow-up visit to complete safety evaluations for approximately 15 days after study drug administration in cohort 1; and 1 days after study drug administration in Cohort 2. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03601715 -
Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.
|
N/A | |
| Completed |
NCT02145273 -
Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
|
N/A | |
| Recruiting |
NCT01985152 -
A Phase Ⅰa Study of Azilsartan Trimethylethanolamine in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT00970398 -
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
|
N/A | |
| Completed |
NCT00332137 -
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
|
Phase 2 | |
| Recruiting |
NCT06060379 -
Giochiamo 626 - Gaming for Health and Safety in Workplaces
|
N/A | |
| Completed |
NCT04998266 -
Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees
|
N/A | |
| Completed |
NCT01214278 -
Bioavailability of Different n-3 Fatty Acid Formulations
|
Phase 4 | |
| Recruiting |
NCT06157346 -
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
|
||
| Completed |
NCT01057368 -
The Effects of Well-being Interventions on Affect, Attention, Sleep, Social Stress and Pain Regulation
|
N/A | |
| Completed |
NCT01216605 -
Oxytocin and Emotion Recognition
|
Phase 4 | |
| Completed |
NCT02287441 -
Feasibility Study to Increase Vegetable Consumption
|
N/A | |
| Recruiting |
NCT02132741 -
Optical Coherence Tomography And NEphropathy: The OCTANE Study
|
||
| Completed |
NCT01762553 -
TEA for Families and Children: A Randomized Intervention Trial
|
N/A | |
| Completed |
NCT01123772 -
Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
|
Phase 1 | |
| Completed |
NCT03527654 -
SER Hispano Longitudinal Study
|
||
| Completed |
NCT03414346 -
Analysis of the Effects on Human Tissues After Application of Therapeutic Modalities.
|
N/A | |
| Completed |
NCT02116283 -
Mobile Sensing of Smoking Behavior
|
N/A | |
| Completed |
NCT05104385 -
Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences
|
||
| Completed |
NCT00962195 -
The Effect of Purple Sweet Potato (PSP)-Juice on Liver Enzymes and Blood Pressure
|
N/A |