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

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

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Secaucus, New Jersey, United States, 07094
        • SPARC Site 01

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 to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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:

  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 who need to maintain mental alertness throughout the study
  4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SPARC001 type I
Treatment type I
Drug: SPARC001 type I
Treatment type I
Drug: SPARC001 type II
Treatment type II
Drug: Reference001 type I
Hydrocodone-acetaminophen
Drug: Reference001 type II
Hydrocodone Acetaminophen
EXPERIMENTAL: SPARC001 type II
Treatment type II
Drug: SPARC001 type I
Treatment type I
Drug: SPARC001 type II
Treatment type II
Drug: Reference001 type I
Hydrocodone-acetaminophen
Drug: Reference001 type II
Hydrocodone Acetaminophen
ACTIVE_COMPARATOR: Reference001 type I
Hydrocodone-Acetaminophen
Drug: SPARC001 type I
Treatment type I
Drug: SPARC001 type II
Treatment type II
Drug: Reference001 type I
Hydrocodone-acetaminophen
Drug: Reference001 type II
Hydrocodone Acetaminophen
ACTIVE_COMPARATOR: Reference type II
Hydrocodone-Acetaminophen
Drug: SPARC001 type I
Treatment type I
Drug: SPARC001 type II
Treatment type II
Drug: Reference001 type I
Hydrocodone-acetaminophen
Drug: Reference001 type II
Hydrocodone Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC
Time Frame: 48 hours
48 hours
Cmax
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event
Time Frame: 25 days
25 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)

February 6, 2017

Primary Completion (ACTUAL)

March 15, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

December 8, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 13, 2016

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

Other Study ID Numbers

  • CLR_16_29

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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