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

NCT02991261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-05-03

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-03-15
Completion
2017-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02991261 on ClinicalTrials.gov