A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
- Availability for the entire study period and willingness to adhere to protocol
- Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
- 18 years of age or older
- No evidence of underlying disease (except multiple myeloma)
- Informed consent form given in written form according
- Female patients of child bearing potential practicing an acceptable method of birth
control for the duration of the study as judged by the investigator(s), such as
condoms, foams, jellies,diaphragm, intrauterine device (IUD), or abstinence
postmenopausal for at least 1 year surgically sterile (bilateral tubal ligation,
bilateral oophorectomy, or hysterectomy has been performed on the subject)
History or presence of significant:
- Allergy or Significant history of hypersensitivity or idiosyncratic reactions to
- Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine,
immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational
drug within past one year.
- Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
- Positive result to HIV, HCV, RPR and HBsAg.
- 12 lead ECG, X-ray and 2D-Echocardiography finding.
Patients shall be excluded for any of the following laboratory results:
- Donation of 350 mL or more of blood in the last 90 days
- Participation in another clinical trial within the preceding 90 days of study start