Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers
NCT ID: NCT02991261
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2017-02-06
2017-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers
NCT02991222
Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects
NCT05102552
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
NCT01053520
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
NCT02326233
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
NCT02805556
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Hydrocodone-Acetaminophen
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
Hydrocodone-Acetaminophen
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-acetaminophen
Reference001 type II
Hydrocodone Acetaminophen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPARC001 type I
Treatment type I
SPARC001 type II
Treatment type II
Reference001 type I
Hydrocodone-acetaminophen
Reference001 type II
Hydrocodone Acetaminophen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 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
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
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SPARC Site 01
Secaucus, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLR_16_29
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.