Status:

COMPLETED

A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Lead Sponsor:

Sun Pharma Advanced Research Company Limited

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Safety and bioequivalence of SPARC\_147709

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2011

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00863174

Start Date

November 1 2010

End Date

April 1 2011

Last Update

May 3 2019

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