WHO ICTRP trial
Comparative Bioavailability of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil…
CTRI/2021/01/030278 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2021/01/030278 |
|---|---|
| Public title | Comparative Bioavailability of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule with Teysuno, (containing Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg) capsule in human subjects with metastatic gastric cancer. |
| Scientific title | An Open label, Randomized, two period, two treatment two sequence, Crossover, Single dose, bioequivalence study for FDC of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule (Test formulation) manufactured by BDR Pharmaceuticals Internationals Pvt. Ltd., Mumbai Versus Teysuno, (containing… |
| Primary sponsor | BDR Pharmaceuticals Internationals Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | BA/BE |
| Countries | India |
| Conditions | Health Condition 1: C162- Malignant neoplasm of body of stomach |
| Interventions | Intervention1: FDC of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule: FDC of Tegafur 20 mg, Gemiracil 5.8 mg, and Oteracil 15.8 mg capsule Manufactured by: BDR Pharmaceuticals Internationals Pvt. Ltd., Mumbai Control… |
| Registration date | Jun 1, 2021 |
| Target size | 42 |
| Secondary IDs | NIL |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: