E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No condition is investigated. The primary aim is to investigate the pharmacokinetics of the new formulation |
Geen specifieke aandoening wordt onderzocht. Het primaire doel is het onderzoeken van de farmacokinetiek van de nieuwe formulering |
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E.1.1.1 | Medical condition in easily understood language |
Bloodlevels of Dexamphetamine |
Bloedspiegels van dexamfetamine |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behaviours [F01] |
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 |
The main objective of this study is to determine the release profile of the dexamphetamine sustained release tablets in vivo in humans |
Het primaire doel van deze studie is het onderzoeken van het afgifteprofiel van de dexamfetamine gereguleerde afgifte tabletten in vivo in mensen |
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E.2.2 | Secondary objectives of the trial |
A second study objective is to assess whether the dried blood spot (DBS) technique can be used to measure dexamphetamine concentrations instead of by venipuncture in order to reduce subject burden. |
Een tweede doel van het onderzoek is te beoordelen of gedroogde bloedspots geschikt zijn voor het meten van dexamfetamine in bloed zodat de patiëntbelasting verminderd kan worden. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participate in a heroin assisted treatment program 2. Have completed at least 80% of the study visits of the CATCH-study; 3. Be at least 25 years old; 4. Be able and willing to participate in the study treatment and assessments; 5. Have provided written informed consent.
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1. Deelnemen aan een heroïne geassisteerd behandelingsprogramma 2. Deelgenomen aan ten minste 80% van de CATCH-studie; 3. Ten minste 25 jaar oud zijn; 4. In staat moet zijn en moet willen deelnemen; 5. Moet geschreven geïnformeerde toestemming hebben gegeven. |
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E.4 | Principal exclusion criteria |
1. Any intake of dexamphetamine 7 days or less before the start of the proposed study; 2. Severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality), which constitute a contraindication for participation; 3. (desired) Pregnancy or continued lactation; 4. Insufficient command of the Dutch language; 5. Current participation in another trial;
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1. Enige inname van dexamfetamine in de laatste 7 dagen voor het starten van de deelname; 2. Ernstige medische aandoeningen hebben die een contraindicatie kunnen zijn voor de studiemedicatie; 3. (Gewenste) Zwangerschap of lactatie; 4. Onvoldoende beheersing van de Nederlandse taal; 5. Huidige deelname aan een andere studie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic properties of the new dexamphetamine sustained release formulation. |
Farmacokinetische eigenschappen van de dexamfetamine gereguleerde afgifte formulering |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the 5 days of the study |
Na de 5 dagen van de studie |
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E.5.2 | Secondary end point(s) |
Not applicable |
Niet van toepassing |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet van toepassing |
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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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
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 | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | 10 |