Pain, Postoperative Clinical Trial
Official title:
A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) Under Fasted Conditions in Healthy Male and Female Adult Subjects
This clinical trial is being conducted to compare concentrations of hydrocodone and
acetaminophen in the blood after administration of different amounts of tablets of a new and
a marketed tablet formulation in healthy adults.
Part 1 is a randomized, single-site, open-label, 4-treatment, 4-period crossover, single oral
dose Phase I trial in 32 healthy male and female subjects. Part will consist of an Enrollment
Visit, 4 treatment periods (each lasting approximately 90 hours), and a Final Examination.
The treatment periods will be separated by a washout period each lasting at least 7 days.
Part 2 is optional and depending on pharmacokinetic data review after Part 1. It is a
randomized, single-site, open-label, 2-treatment, 2-period crossover, single oral dose part
in healthy male and female subjects. Part 2 will consist of an Enrollment Visit, 2 treatment
periods (each lasting approximately 90 hours) and a Final Examination. The treatment periods
will be separated by a washout period lasting at least 7 days.
Participants must fast for approximately 10 hours prior to administration of Investigational
medicinal product (IMP) and until approximately 4 hours after the administration of the IMP.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05480111 -
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
|
Phase 4 | |
| Completed |
NCT06129305 -
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
|
||
| Completed |
NCT04401826 -
Micro-surgical Treatment of Gummy Smile
|
N/A | |
| Recruiting |
NCT04020133 -
the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.
|
N/A | |
| Completed |
NCT03023462 -
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
|
N/A | |
| Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
| Completed |
NCT03546738 -
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery
|
N/A | |
| Terminated |
NCT03261193 -
ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain
|
Phase 3 | |
| Withdrawn |
NCT03528343 -
Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy
|
Phase 1/Phase 2 | |
| Completed |
NCT02525133 -
Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty
|
Phase 3 | |
| Completed |
NCT03244540 -
Regional Analgesia After Cesarean Section
|
Phase 4 | |
| Enrolling by invitation |
NCT05316168 -
Post Operative Pain Management for ACL Reconstruction
|
Phase 3 | |
| Recruiting |
NCT04130464 -
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
|
Phase 4 | |
| Enrolling by invitation |
NCT04574791 -
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty
|
N/A | |
| Completed |
NCT04526236 -
Influence of Aging on Perioperative Methadone Dosing
|
Phase 4 | |
| Completed |
NCT04073069 -
Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults
|
Phase 4 | |
| Recruiting |
NCT05351229 -
Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
|
Phase 4 | |
| Enrolling by invitation |
NCT05543109 -
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block
|
N/A | |
| Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
| Completed |
NCT04919317 -
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
|
Phase 2 |