Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Feb 2017
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedStudy Start
First participant enrolled
February 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 3, 2019
May 1, 2019
1 month
December 8, 2016
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
AUC
48 hours
Cmax
48 hours
Secondary Outcomes (1)
Adverse event
25 days
Study Arms (4)
SPARC001 type I
EXPERIMENTALTreatment type I
SPARC001 type II
EXPERIMENTALTreatment type II
Reference001 type I
ACTIVE COMPARATORHydrocodone-Acetaminophen
Reference type II
ACTIVE COMPARATORHydrocodone-Acetaminophen
Interventions
Treatment type I
Treatment type II
Hydrocodone-acetaminophen
Hydrocodone Acetaminophen
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPARC Site 01
Secaucus, New Jersey, 07094, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2016
First Posted
December 13, 2016
Study Start
February 6, 2017
Primary Completion
March 15, 2017
Study Completion
April 1, 2017
Last Updated
May 3, 2019
Record last verified: 2019-05