WHO ICTRP trial
Comparison to assess similarity of a new medicine (Neopharmed Gentili S.r.l.)…
ISRCTN17559039 · International Standard Randomised Controlled Trial Number (ISRCTN) · Not Recruiting
Key facts
| Trial ID | ISRCTN17559039 |
|---|---|
| Public title | Comparison to assess similarity of a new medicine (Neopharmed Gentili S.r.l.) versus the simultaneous administration of Triatec® (Sanofi-Aventis) and Congescor® (Daiichi Sankyo) |
| Scientific title | Bioequivalence study of a novel ramipril 10 mg/bisoprolol fumarate 5 mg hard capsule fixed dose combination (Neopharmed Gentili S.r.l.) versus a free combination of ramipril 10 mg tablets (Triatec®, Sanofi-Aventis) and bisoprolol fumarate 5 mg filmcoated tablets (Congescor®, Daiichi Sankyo) in… |
| Primary sponsor | Neopharmed Gentili S.r.l. |
| Registry | International Standard Randomised Controlled Trial Number (ISRCTN) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase I |
| Countries | Switzerland |
| Conditions | Not applicable, this is s Bioequivalence study Not Applicable |
| Interventions | The following visits were performed: Screening phase -Screening – visit 1: between Day -14 and Day -2 -Period 1 – visit 2: Day -1 Interventional phase -Period 1 – visit 3: Days 1-3 -Wash-out interval of at least 14 days -Period 2 – visit 4… |
| Registration date | Apr 18, 2019 |
| Target size | 36 |
| Secondary IDs | Nil known;Nil known;Study CRO-PK-18-328 - Sponsor code NG8706/1-C02 |
| Registry page | isrctn.com |
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: