Status and phase
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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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female, 18 to 55 years of age inclusive at the time of signing the informed consent form
Body weight must be above 60 kg.
Body Mass Index (BMI) 18 to 40 kg/m2
In good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
If male, must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period until the final PK sample, and refrain from donating sperm for 90 days after the dosing.
If female, is not pregnant (see Appendix 5), not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period until the last PK sample.
Vital signs (after 3 minutes resting in a semi-supine position) which are within the following ranges:
Fasting blood glucose, <110 mg/dL.
Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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