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OpenTrials
Completed

NCT Number: NCT02618395

Bioavailability Study of SPARC001 in Healthy Adult Volunteers

Bioavailability study

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Bioavailability, safety and tolerability

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
  • 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

Treatment and study plan

SPARC001A

Drug

SPARC001B

Drug

Reference001 - Hydrocodone

Drug

Hydrocodone-acetaminophen

Primary outcomes

  1. Maximum plasma hydrocodone and acetaminophen concentration (Cmax)

    Time frame: 17 days

Secondary outcomes

  1. AUC extrapolated to infinity (AUC0 ∞)

    Time frame: 17 days

  2. Time to Cmax (tmax)

    Time frame: 17 days

  3. Elimination half-life (t½)

    Time frame: 17 days

  4. Treatment emergent adverse event

    Time frame: 17 days

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
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.

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