Overview

This trial has been completed.

Condition healthy
Treatments sparc001a, sparc001b, reference001 - hydrocodone
Phase phase 1
Sponsor Sun Pharma Advanced Research Company Limited
Start date December 2015
End date April 2016
Trial size 18 participants
Trial identifier NCT02618395, SUN-HBA-PK001

Summary

Bioavailability study

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sparc001a
(Experimental)
sparc001b
(Experimental)
reference001 - hydrocodone
Hydrocodone-acetaminophen

Primary Outcomes

Measure
Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
time frame: 17 days

Secondary Outcomes

Measure
AUC extrapolated to infinity (AUC0 ∞)
time frame: 17 days
Time to Cmax (tmax)
time frame: 17 days
Elimination half-life (t½)
time frame: 17 days
Treatment emergent adverse event
time frame: 17 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Description Bioavailability, safety and tolerability
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Sun Pharma Advanced Research Company Limited.