Breast Cancer and Ovarian Cancer Clinical Trial
Official title:
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
| Verified date | July 2021 |
| Source | Sun Pharma Advanced Research Company Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | November 28, 2009 |
| Est. primary completion date | November 28, 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: 1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years. 3. Subjects who had no evidence of underlying disease 4. Subjects who had signed written consent form Exclusion Criteria: 1. Females who were pregnant, breastfeeding, or are likely to become pregnant 2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results 3. Subjects deemed uncooperative or noncompliant 4. Smoking or consumption of any nicotine products |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharma Advanced Research Company Limited |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum measured plasma concentration | 336 hours | ||
| Secondary | The area under the plasma concentration versus time curve from time 0 to infinity | 336 hours |