WHO ICTRP trial
Bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg…
CTRI/2023/09/057205 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2023/09/057205 |
|---|---|
| Public title | Bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., in comparison with Nitromint® Retard Controlled Release tablet 2.6 mg (Nitroglycerin) of M/s Egis Pharma, Hungary in healthy, adult, human subjects under fasting condition. |
| Scientific title | An open label, balanced, randomized, two-treatment, two period, two-sequence, single oral dose, crossover, bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., in comparison with Nitromint® Retard Controlled Release tablet 2.6 mg… |
| Primary sponsor | Modi-Mundi Pharma Pvt. Ltd. |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | BA/BE |
| Countries | India |
| Interventions | Intervention1: Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin): Name of the drug:Nitroglycerin 2.6 mg controlled release tablet Route of administration: Oral Frequency: single oral dose Study duration:09 days Control… |
| Registration date | Jan 9, 2023 |
| Target size | 32 |
| Secondary IDs | ICBio/043/0922 Version 00 Dated 16 Sep 2022 |
| 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: