Skip to main content
OpenTrials
Completed

NCT Number: NCT02991261

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 01

Secaucus, New Jersey, 07094, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
  • Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight >50 kg (110 lbs) at Screening
  • All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
  • 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

  • Females who are pregnant, lactating, or likely to become pregnant during the study
  • Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
  • Subjects who need to maintain mental alertness throughout the study
  • Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results

Treatment and study plan

SPARC001 type I

Drug

Treatment type I

SPARC001 type II

Drug

Treatment type II

Reference001 type I

Drug

Hydrocodone-acetaminophen

Reference001 type II

Drug

Hydrocodone Acetaminophen

Primary outcomes

  1. AUC

    Time frame: 48 hours

  2. Cmax

    Time frame: 48 hours

Secondary outcomes

  1. Adverse event

    Time frame: 25 days

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2016
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.