WHO ICTRP trial
This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib…
CTRI/2013/04/003546 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2013/04/003546 |
|---|---|
| Public title | This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of (GLIVEC®)Novartis Europharm Limited, United Kingdom in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition. |
| Scientific title | A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, multiple dose, comparative oral bioavailability study of Imatinib mesylate tablets 400mg of Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), India with GLIVEC® (Imatinib… |
| Primary sponsor | Onco Therapies Limited which is a subsidiary of Strides Arcolab Ltd |
| Secondary sponsors | Veeda clinical research Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: null- Chronic Myeloid Leukemia |
| Interventions | Intervention1: GLIVEC® (Imatinib Mesylate) tablets 400 mg tablet: 400 mg of Onco Therapies Limited Intervention2: Imatinib mesylate tablets 400mg tablet once daily: Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), India… |
| Registration date | Nov 4, 2013 |
| Target size | 32 |
| Secondary IDs | 12-VIN-108 Version 01 dated 30 March 2012 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: