Bioavailability Study of SPARC001 in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SPARC001B; Drug: Reference001 - Hydrocodone; Drug: SPARC001A

• Registration Number: NCT02618395
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Bioavailability study

Detailed Description

Bioavailability, safety and tolerability

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Study Start: 2015-12-28
• Primary Completion: 2016-01-25
• Study Completion: 2016-01-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	SPARC001B	-
Treatment C	Reference001 - Hydrocodone	-
Treatment A	SPARC001A	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)	17 days

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse event	17 days
AUC extrapolated to infinity (AUC0 ∞)	17 days
Elimination half-life (t½)	17 days
Time to Cmax (tmax)	17 days