Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02991261

Run by

Sun Pharma Advanced Research Company Limited

People needed

24

Starts

2017-02-06

Expected to finish

2017-04-01

Last updated by the study team

2019-05-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• SPARC Site 01 — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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