WHO ICTRP trial
Comparative in vivo evaluation of 2 Apremilast 30mg ER Tablet and Otezla® Tablet…
IRCT20180620040164N81 · Iranian Registry of Clinical Trials (IRCT) · Not Recruiting
Key facts
| Trial ID | IRCT20180620040164N81 |
|---|---|
| Public title | Comparative in vivo evaluation of 2 Apremilast 30mg ER Tablet and Otezla® Tablet formulations. |
| Scientific title | Comparative bioequivalence study of Apremilast 30 mg Tablet of Zist Arvand Pharmed. and Otezla® of AMGEN as reference in 24 healthy male under fasting condition |
| Primary sponsor | Zist Arvand Pharme Ltd. |
| Registry | Iranian Registry of Clinical Trials (IRCT) |
| Recruitment status | Not Recruiting |
| Study type | interventional |
| Phase | Bioequivalence |
| Countries | Iran (Islamic Republic of) |
| Conditions | Psoriasis. Psoriasis |
| Interventions | Intervention 1: Intervention group 1: Apremilast 30 mg Tablet, produced by Zist arvand Pharmed. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention 2: Intervention group 2… |
| Registration date | Jan 27, 2025 |
| Target size | 24 |
| Registry page | irct.behdasht.gov.ir |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: