Healthy
Conditions
Brief summary
Bioavailability study
Detailed description
Bioavailability, safety and tolerability
Interventions
DRUGSPARC001A
DRUGSPARC001B
DRUGReference001 - Hydrocodone
Hydrocodone-acetaminophen
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult, male and female volunteers, 18 to 55 years of age * Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening * Female subjects must have a negative serum pregnancy test * Medically healthy on the basis of medical history and physical examination
Exclusion criteria
* Females who are pregnant, lactating, or likely to become pregnant during the study * Life-time history and/or recent evidence of alcohol * History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations * Subjects with any condition in which an opioid is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma hydrocodone and acetaminophen concentration (Cmax) | 17 days |
Secondary
| Measure | Time frame |
|---|---|
| AUC extrapolated to infinity (AUC0 ∞) | 17 days |
| Time to Cmax (tmax) | 17 days |
| Elimination half-life (t½) | 17 days |
| Treatment emergent adverse event | 17 days |
Outcome results
None listed