Healthy
Conditions
Brief summary
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
Interventions
DRUGSPARC001 type I
Treatment type I
DRUGSPARC001 type II
Treatment type II
Hydrocodone-acetaminophen
Hydrocodone Acetaminophen
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit 2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at Screening 3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit 4. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.
Exclusion criteria
1. Females who are pregnant, lactating, or likely to become pregnant during the study 2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder 3. Subjects who need to maintain mental alertness throughout the study 4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC | 48 hours |
| Cmax | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | 25 days |
Countries
United States
Outcome results
None listed