Bioavailability Study of SPARC001 in Healthy Adult Volunteers

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SPARC001A; Drug: Reference001 - Hydrocodone; Drug: SPARC001B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02618395

SUN-HBA-PK001

Details and patient eligibility

About

Bioavailability study

Full description

Bioavailability, safety and tolerability

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Treatment A

Experimental group

Treatment:

Drug: SPARC001A

Treatment B

Experimental group

Treatment:

Drug: SPARC001B

Treatment C

Experimental group

Treatment:

Drug: Reference001 - Hydrocodone