A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: SPARC147709; Drug: Reference147709

• Registration Number: NCT00863174
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Safety and bioequivalence of SPARC_147709

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Study Start: 2010-11
• Primary Completion: 2011-01
• Study Completion: 2011-04
• 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

• Availability for the entire study period and willingness to adhere to protocol requirements.
• Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
• 18 years of age or older
• No evidence of underlying disease (except multiple myeloma)

Exclusion Criteria

• History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
• History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
• History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
• Positive result to HIV, HCV, RPR and HBsAg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SPARC147709	SPARC147709
2	Reference147709	Reference147709

Primary Outcome Measures

Name	Time	Method
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference	2 cycles

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	2 cycles