Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/16/2018 |
| Start Date: | February 6, 2017 |
| End Date: | April 1, 2017 |
A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
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
tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
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
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