Bioavailability Study of SPARC001 in Healthy Adult Volunteers

May 2, 2019 updated by: Sun Pharma Advanced Research Company Limited
Bioavailability study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bioavailability, safety and tolerability

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment B
Drug: SPARC001B
Experimental: Treatment C
Drug: Reference001 - Hydrocodone
Hydrocodone-acetaminophen
Experimental: Treatment A
Drug: SPARC001A

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC extrapolated to infinity (AUC0 ∞)
Time Frame: 17 days
17 days
Time to Cmax (tmax)
Time Frame: 17 days
17 days
Elimination half-life (t½)
Time Frame: 17 days
17 days
Treatment emergent adverse event
Time Frame: 17 days
17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2015

Primary Completion (Actual)

January 25, 2016

Study Completion (Actual)

January 25, 2016

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN-HBA-PK001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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