Bioavailability Study of SPARC001 in Healthy Adult Volunt... | NCT02618395

Studies
Bioavailability Study of SPARC001 in Healthy Adult Volunteers

NCT02618395

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Completed

Last Update Posted

May 3, 2019Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy

Interventions

SPARC001A
SPARC001B
Reference001 - Hydrocodone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2015Actual

Primary Completion Date

Jan 25, 2016Actual

Completion Date

Jan 25, 2016Actual

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 25, 2015

First Posted Date

Dec 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2019

Last Update Posted Date

May 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment A	Experimental	Drug: SPARC001A
Treatment B	Experimental	Drug: SPARC001B
Treatment C	Experimental	Drug: Reference001 - Hydrocodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPARC001A	Drug		Treatment A
SPARC001B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)		17 days

Secondary Outcomes

Measure	Description	Time Frame
AUC extrapolated to infinity (AUC0 ∞)		17 days
Time to Cmax (tmax)		17 days
Elimination half-life (t½)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided