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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: SPARC001 type I
* Drug: SPARC001 type II
* Drug: Reference001 type I
* Drug: Reference001 type II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC001 type I<br>Treatment type I | Drug: SPARC001 type I<br>* Treatment type I<br>Drug: SPARC001 type II<br>* Treatment type II<br>Drug: Reference001 type I<br>* Hydrocodone-acetaminophen<br>Drug: Reference001 type II<br>* Hydrocodone Acetaminophen<br>|
| Experimental: SPARC001 type II<br>Treatment type II | Drug: SPARC001 type I<br>* Treatment type I<br>Drug: SPARC001 type II<br>* Treatment type II<br>Drug: Reference001 type I<br>* Hydrocodone-acetaminophen<br>Drug: Reference001 type II<br>* Hydrocodone Acetaminophen<br>|
| Active Comparator: Reference001 type I<br>Hydrocodone-Acetaminophen | Drug: SPARC001 type I<br>* Treatment type I<br>Drug: SPARC001 type II<br>* Treatment type II<br>Drug: Reference001 type I<br>* Hydrocodone-acetaminophen<br>Drug: Reference001 type II<br>* Hydrocodone Acetaminophen<br>|
| Active Comparator: Reference type II<br>Hydrocodone-Acetaminophen | Drug: SPARC001 type I<br>* Treatment type I<br>Drug: SPARC001 type II<br>* Treatment type II<br>Drug: Reference001 type I<br>* Hydrocodone-acetaminophen<br>Drug: Reference001 type II<br>* Hydrocodone Acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 48 hours | 
| Cmax |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event |  | 25 days |