- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01704846
Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Sumida-ku,Tokyo, Japon
- 1220.53.08101 Boehringer Ingelheim Investigational Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
- Healthy male volunteers without any clinical significant findings and complications
- Age: 20 - 45 years
- BMI: 18.5 - 25.0 kg/m2
- Signed informed consent
Exclusion criteria:
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
- Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- History of jaundice
- Surgery of the gastrointestinal tract (except appendectomy).
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections.
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
- Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial.
- Participation in another trial with an investigational drug within two months prior to administration or during the trial.
- Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
- Inability to refrain from smoking during the trial.
- Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
- Drug abuse.
- Blood donation (more than 100 mL within four weeks prior to administration).
- Excessive physical activities (within one week prior to administration).
- Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
- Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treatment sequence 1
Test - Reference - Reference - Test
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1capsule of BI 201335 NA 120 mg capsule
1 capsule of BI 201335 NA 120 mg capsule
3 capsules of BI 201335 NA 40 mg capsule
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Expérimental: Treatment sequence 2
Reference - Test - Test - Reference
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1capsule of BI 201335 NA 120 mg capsule
1 capsule of BI 201335 NA 120 mg capsule
3 capsules of BI 201335 NA 40 mg capsule
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation. |
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Maximum Measured Concentration (Cmax)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Maximum measured concentration of faldaprevir in plasma.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
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3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation. |
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Time From Dosing to the Maximum Measured Concentration (Tmax)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Time from dosing to the maximum measured concentration of the analyte in plasma. Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation. |
3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Terminal Rate Constant (λz)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Terminal rate constant of the analyte in plasma.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
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3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Terminal Half-life (t1/2)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Terminal half-life of faldaprevir in plasma.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
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3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Mean Residence Time (MRTpo)
Délai: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Mean residence time of the analyte in the body after oral administration.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
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3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1220.53
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Essais cliniques sur BI 201335 NA 120 mg capsule
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Boehringer IngelheimComplétéHépatite C chroniqueÉtats-Unis, Argentine, Australie, L'Autriche, Canada, République tchèque, France, Allemagne, Corée, République de, Pays-Bas, Le Portugal, Roumanie, Espagne, Suisse, Royaume-Uni
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