E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
• Administering one tablet of Noxafil with a glass of 240 ml of water • Administering four tablets of Noxafil with a glass of 240 ml of water • Administering one tablet of Noxafil with a glass of 240 ml of water, prior to the intake of 400 ml Ensure plus (liquid meal) • Administering four tablets of Noxafil with a glass of 240 ml of water, prior to the intake of 400 ml Ensure plus (liquid meal) |
• Toediening van 1 tablet in met 240 ml plat water • Toediening van 4 tabletten met 240 ml plat water • Toediening van 1 tablet met 240 ml water, voorafgegaan door inname van 400 ml vloeibare voeding • Toediening van 4 tabletten met 240 ml water, voorafgegaan door inname van 400 ml vloeibare voeding
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E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (18-40 years) |
Gezonde vrijwilligers (18-40 jaar) |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Study of the gastrointestinal behavior of posaconazol in healthy volunteers by using Noxafil tablet. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...)
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Studie van het gastrointestinaal gedrag van posaconazol in gezonde vrijwilligers door gebruik te maken van Noxafil tablet. Dit zal leiden tot meer inzicht in het GI gedrag van posaconazol (optreden van supersaturatie/ precipitatie/ in oplossing gaan/ ...) |
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E.2.2 | Secondary objectives of the trial |
To see if there is any difference in disposition of the tablet in fasting or postprandial conditions |
Verkennen of er een verschil is in het gedrag van de tablet na orale inname tussen een gevaste toestand of gevoede toestand. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Healthy volunteers -age between 18 and 40 years old
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-Gezonde vrijwilligers -Leeftijd tussen de 18 en 40 jaar |
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E.4 | Principal exclusion criteria |
-pregnancy -disease -use of medication
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-zwangerschap -ziekte -gebruik van medicatie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Not applicable |
Niet toepasbaar |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet toepasbaar |
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E.5.2 | Secondary end point(s) |
Not applicable |
Niet toepasbaar |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet toepasbaar |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Evaluatie van het gastrointestinaal gedrag van posaconazol in 4 verschillende condities |
Evaluation of the gastrointestinal behavior of posaconazol in 4 different conditions |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of last subject |
laatste bezoek van laatste vrijwilliger |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |