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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SPARC001 type I; Drug: SPARC001 type II; Drug: Reference001 type I; Drug: Reference001 type II

• Registration Number: NCT02991261
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Study Start: 2017-02-06
• Primary Completion: 2017-03-15
• Study Completion: 2017-04-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPARC001 type I	SPARC001 type II	Treatment type I
SPARC001 type II	Reference001 type II	Treatment type II
Reference001 type I	SPARC001 type I	Hydrocodone-Acetaminophen
Reference001 type I	Reference001 type I	Hydrocodone-Acetaminophen
SPARC001 type II	SPARC001 type I	Treatment type II
Reference001 type I	Reference001 type II	Hydrocodone-Acetaminophen
SPARC001 type I	SPARC001 type I	Treatment type I
SPARC001 type I	Reference001 type I	Treatment type I
Reference type II	Reference001 type I	Hydrocodone-Acetaminophen
SPARC001 type I	Reference001 type II	Treatment type I
SPARC001 type II	SPARC001 type II	Treatment type II
Reference type II	SPARC001 type I	Hydrocodone-Acetaminophen
Reference type II	Reference001 type II	Hydrocodone-Acetaminophen
SPARC001 type II	Reference001 type I	Treatment type II
Reference001 type I	SPARC001 type II	Hydrocodone-Acetaminophen
Reference type II	SPARC001 type II	Hydrocodone-Acetaminophen

Primary Outcome Measures

Name	Time	Method
Cmax	48 hours
AUC	48 hours

Secondary Outcome Measures

Name	Time	Method
Adverse event	25 days

Trial Locations

Locations (1)

SPARC Site 01; 🇺🇸 Secaucus, New Jersey, United States