A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: SPARC147709; Drug: Reference147709

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863174

DOX_21_1477_09

Details and patient eligibility

About

Safety and bioequivalence of SPARC_147709

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Experimental group

Description:

SPARC147709

Treatment:

Drug: SPARC147709

2

Active Comparator group

Description:

Reference147709

Treatment:

Drug: Reference147709