NCT02618395

Brief Summary

Bioavailability study

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

December 28, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2016

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

28 days

First QC Date

November 23, 2015

Last Update Submit

May 2, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Maximum plasma hydrocodone and acetaminophen concentration (Cmax)

    17 days

Secondary Outcomes (4)

  • AUC extrapolated to infinity (AUC0 ∞)

    17 days

  • Time to Cmax (tmax)

    17 days

  • Elimination half-life (t½)

    17 days

  • Treatment emergent adverse event

    17 days

Study Arms (3)

Treatment A

EXPERIMENTAL
Drug: SPARC001A

Treatment B

EXPERIMENTAL
Drug: SPARC001B

Treatment C

EXPERIMENTAL
Drug: Reference001 - Hydrocodone

Interventions

SPARC001ADRUG
Treatment A
SPARC001BDRUG
Treatment B
Reference001 - HydrocodoneDRUG

Hydrocodone-acetaminophen

Treatment C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, male and female volunteers, 18 to 55 years of age
  • Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
  • Female subjects must have a negative serum pregnancy test
  • Medically healthy on the basis of medical history and physical examination

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
  • History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
  • Subjects with any condition in which an opioid is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 1, 2015

Study Start

December 28, 2015

Primary Completion

January 25, 2016

Study Completion

January 25, 2016

Last Updated

May 3, 2019

Record last verified: 2019-05