Relative Bioavailability of Dabigatran Capsules, Pellets and Oral Solution in Healthy Volunteers
1 maj 2015 uppdaterad av: Boehringer Ingelheim
Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pellets on Food) in Healthy Male Volunteers (an Open-label, Randomised, Multiple-dose, Three Way Crossover Study)
To investigate the relative bioavailability of dabigatran etexilate as pellets on food and of dabigatran etexilate as granules resolved in reconstitution solution, each with dabigatran etexilate as capsule following oral administration.
To evaluate acceptability and palatability of Pellets sprinkled on food and Oral Liquid Formulation
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
54
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Biberach, Tyskland
- 1160.194.1 Boehringer Ingelheim Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion criteria:
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
- Age 18 to 55 years (incl.)
- Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
- Any finding in the medical examination (including Blood Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Subjects who in the investigator's judgement are perceived as having an increased risk of bleeding, for example because of:
- Hemorrhagic disorders or bleeding diathesis
- Occult blood in faeces or haematuria
- Trauma or surgery within the last month or as long as an excessive risk of bleeding persists after these events, or planned surgery during trial participation
- History of arteriovenous malformation or aneurysm
- History of gastroduodenal ulcer disease or gastrointestinal haemorrhage
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intraarticular bleeding
- Anemia at screening
- Thrombocytopenia (platelet count less than 100/nL)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Test 1 (Treatment A)
multiple dose of dabigatran
|
Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
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Experimentell: Test 2 (Treatment B)
multiple dose of dabigatran
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Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
|
|
Experimentell: Reference
multiple dose of dabigatran
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Pellets (multiple dose of dabigatran)
Granules resolved in reconstitution solution (multiple dose of dabigatran)
Hard capsule (multiple dose of dabigatran)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
Tidsram: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
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Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.
Tidsram: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
Tidsram: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
|
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.
Tidsram: 47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.
|
47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration
|
|
Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
Tidsram: once on day 3 (48 hours after first dose)
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Acceptability question: "Would you accept to take this medication for chronic use?" with 3 possible answers: Yes - No - I am not sure.
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once on day 3 (48 hours after first dose)
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Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.
Tidsram: once on day 3 (48 hours after first dose)
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Palatability question: "How do you rank the taste?" with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable.
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once on day 3 (48 hours after first dose)
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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2014
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
22 januari 2014
Först inskickad som uppfyllde QC-kriterierna
22 januari 2014
Första postat (Uppskatta)
24 januari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 maj 2015
Senast verifierad
1 maj 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1160.194
- 2013-002498-23 (EudraCT-nummer: EudraCT)
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