Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers

A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001 in Healthy, Adult Volunteers Under Fed and Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02991222

Enrollment

Registered

2016-12-13

Start date

2017-01-15

Completion date

2017-04-30

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGReference001 type I

Hydrocodone-Acetaminophen

DRUGReference001 type II

Hydrocodone-Acetaminophen

DRUGSPARC001 type I

Treatment type I

DRUGSPARC001 type II

Treatment type II

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

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 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

Design outcomes

Primary

Measure	Time frame
AUC	48 hours
Cmax	48 hours

Secondary

Measure	Time frame
Adverse event	25 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026