A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and bioequivalence of SPARC_147709

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

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.