WHO ICTRP trial
A Clinical trial intended to compare two formulations of Capecitabine tablets…
CTRI/2011/11/002171 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2011/11/002171 |
|---|---|
| Public title | A Clinical trial intended to compare two formulations of Capecitabine tablets, in patients with Breast Cancer or Colorectal Cancer. |
| Scientific title | Single-Dose Fed Bioequivalence Study of Capecitabine Tablets (500 mg; Mylan) to Xeloda® Tablets (500 mg; Genentech) in Adult Cancer Patients with Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer. |
| Primary sponsor | Mylan Pharmaceuticals Inc |
| Secondary sponsors | BA Research India Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: null- Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer |
| Interventions | Intervention1: Capecitabine Manufactured by Mylan Pharmaceutical Inc., USA: Each patient will receive a Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose)for 14 days… |
| Registration date | Nov 25, 2011 |
| Target size | 42 |
| Secondary IDs | CAPE 11121 |
| 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: