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A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 17, 2009
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
Safety and bioequivalence of SPARC_147709

Condition Intervention Phase
Multiple Myeloma Drug: SPARC147709 Drug: Reference147709 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference [ Time Frame: 2 cycles ]

Secondary Outcome Measures:
  • Treatment Emergent Adverse Events [ Time Frame: 2 cycles ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: SPARC147709
SPARC147709 injection
Active Comparator: 2
Drug: Reference147709
Reference147709 injection


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00863174     History of Changes
Other Study ID Numbers: DOX_21_1477_09
First Submitted: March 16, 2009
First Posted: March 17, 2009
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Sun Pharma Advanced Research Company Limited:
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases