A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"

Sun Pharma Advanced Research Company Limited1 site in 1 country24 target enrollmentFebruary 6, 2017

ConditionsHealthy

InterventionsReference001 type II SPARC001 type I SPARC001 type II Reference001 type I

DrugsSPARC001 type I SPARC001 type II Reference001 type I Reference001 type II

Overview

Phase: Phase 1
Intervention: Reference001 type II
Conditions: Healthy
Sponsor: Sun Pharma Advanced Research Company Limited
Enrollment: 24
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

February 6, 2017

End Date

April 1, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sun Pharma Advanced Research Company Limited

Responsible Party

Sponsor

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 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

•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 who need to maintain mental alertness throughout the study
•Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results