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

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SPARC001 type II; Drug: Reference001 type II; Drug: Reference001 type I; Drug: SPARC001 type I

Study type: Interventional

Funder types: Industry

Identifiers

NCT02991261

CLR_16_29

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit
2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight >50 kg (110 lbs) at Screening
3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
4. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.

Exclusion criteria

1. Females who are pregnant, lactating, or likely to become pregnant during the study
2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
3. Subjects who need to maintain mental alertness throughout the study
4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

SPARC001 type I

Experimental group

Description:

Treatment type I

Treatment:

Drug: SPARC001 type II

Drug: Reference001 type I

Drug: SPARC001 type I

Drug: Reference001 type II

SPARC001 type II

Experimental group

Description:

Treatment type II

Treatment:

Drug: SPARC001 type II

Drug: Reference001 type I

Drug: SPARC001 type I

Drug: Reference001 type II

Reference001 type I

Active Comparator group

Description:

Hydrocodone-Acetaminophen

Treatment:

Drug: SPARC001 type II

Drug: Reference001 type I

Drug: SPARC001 type I

Drug: Reference001 type II

Reference type II

Active Comparator group

Description:

Hydrocodone-Acetaminophen

Treatment:

Drug: SPARC001 type II

Drug: Reference001 type I

Drug: SPARC001 type I

Drug: Reference001 type II