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NCT00863174 Clinical Trial

A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00863174
Other study ID # DOX_21_1477_09
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2010
Est. completion date April 2011

Study information
Verified date May 2019
Source Sun Pharma Advanced Research Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Safety and bioequivalence of SPARC_147709

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SPARC147709
SPARC147709 injection
• Reference147709
Reference147709 injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Outcome
Type Measure Description Time frame Safety issue
Primary 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-8, of the test and reference 2 cycles
Secondary Treatment Emergent Adverse Events 2 cycles
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