A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001 in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
Overview
- Phase
- Phase 1
- Intervention
- SPARC001 type I
- Conditions
- Healthy
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit;
- •Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at Screening
- •All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
- •Medically healthy on the basis of medical history
Exclusion Criteria
- •Females who are pregnant, lactating, or likely to become pregnant during the study
- •Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
- •Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease
- •Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
Arms & Interventions
SPARC001 type I
Treatment type I
Intervention: SPARC001 type I
SPARC001 type I
Treatment type I
Intervention: SPARC001 type II
SPARC001 type I
Treatment type I
Intervention: Reference001 type I
SPARC001 type I
Treatment type I
Intervention: Reference001 type II
SPARC001 type II
Treatment type II
Intervention: SPARC001 type I
SPARC001 type II
Treatment type II
Intervention: SPARC001 type II
SPARC001 type II
Treatment type II
Intervention: Reference001 type I
SPARC001 type II
Treatment type II
Intervention: Reference001 type II
Reference001 type I
Treatment type I
Intervention: SPARC001 type I
Reference001 type I
Treatment type I
Intervention: SPARC001 type II
Reference001 type I
Treatment type I
Intervention: Reference001 type I
Reference001 type I
Treatment type I
Intervention: Reference001 type II
Reference type II
Treatment type II
Intervention: SPARC001 type I
Reference type II
Treatment type II
Intervention: SPARC001 type II
Reference type II
Treatment type II
Intervention: Reference001 type I
Reference type II
Treatment type II
Intervention: Reference001 type II
Outcomes
Primary Outcomes
AUC
Time Frame: 48 hours
Cmax
Time Frame: 48 hours
Secondary Outcomes
- Adverse event(25 days)