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
Verified date | May 2019 |
Source | Sun Pharma Advanced Research Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Safety and bioequivalence of SPARC_147709
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sun Pharma Advanced Research Company Limited |
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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