Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers
NCT ID: NCT02991222
Last Updated: 2019-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2017-01-15
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SPARC001 type I
Treatment type I
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-Acetaminophen
Reference001 type II
Hydrocodone-Acetaminophen
SPARC001 type II
Treatment type II
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-Acetaminophen
Reference001 type II
Hydrocodone-Acetaminophen
Reference001 type I
Treatment type I
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-Acetaminophen
Reference001 type II
Hydrocodone-Acetaminophen
Reference type II
Treatment type II
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-Acetaminophen
Reference001 type II
Hydrocodone-Acetaminophen
Interventions
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SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-Acetaminophen
Reference001 type II
Hydrocodone-Acetaminophen
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
3. 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
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
18 Years
55 Years
ALL
Yes
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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SPARC Site 01
Secaucus, New Jersey, United States
Countries
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Other Identifiers
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CLR_16_28
Identifier Type: -
Identifier Source: org_study_id
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