WHO ICTRP trial
A Clinical Trial of two drugs Paclitaxel (Test) and Abraxane (Reference) to…
CTRI/2025/05/086951 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2025/05/086951 |
|---|---|
| Public title | A Clinical Trial of two drugs Paclitaxel (Test) and Abraxane (Reference) to study the pharmacokinetics and safety in patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy |
| Scientific title | A Multicenter, Open Label, Randomized, Single Dose, Two Treatment, Two period, Two sequence, Crossover Bioequivalence Study of Paclitaxel Protein bound Particles for Injectable Suspension (Albumin bound) 100 mg per vial (Test) of Amneal EU, Limited, Ireland with Abraxane for Injectable Suspension… |
| Primary sponsor | Amneal EU Limited |
| Secondary sponsors | AXIS Clinicals Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: C509- Malignant neoplasm of breast of unspecified site |
| Interventions | Intervention1: Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin bound)of Amneal EU Limited Ireland: Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) 100 mg per Vial, Each Patient will receive… |
| Registration date | May 14, 2025 |
| Target size | 60 |
| Secondary IDs | CR223-24, Version 1.0 Amendment 01, Dated 17.12.2024 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: