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Pharmacokinetic study of SPARC1613 and Reference1613

A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007565
Enrollment
142
Registered
2016-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metastatic breast cancer

Interventions

Intervention1: SPARC1613: Intravenous infusion of 260 mg/m2 Control Intervention1: Reference1613: Intravenous infusion of 260 mg/m2

Sponsors

Sun Pharma Advanced Research Company Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study 2. Histologically or cytologically confirmed diagnosis of breast cancer 3. Estimated life expectancy of at least 12 weeks 4. ECOG performance status less than 1

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to either of the study drugs or their excipients 2. Inability to undergo venipuncture and/or tolerate venous access 3. Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy 4. Pre-existing clinically significant peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameter Cmax, and AUCTimepoint: Pharmacokinetic parameter Cmax, and AUC—

Secondary

MeasureTime frame
NoneTimepoint: None—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com912266455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026