Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules
3 juli 2015 uppdaterad av: Boehringer Ingelheim
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)
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
60
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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Sumida-ku,Tokyo, Japan
- 1220.53.08101 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
20 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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).
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 |
|---|---|
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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.
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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.
|
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)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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.
|
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)
Tidsram: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
|
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.
|
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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Studieavstämningsdatum
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Studera stora datum
Studiestart
1 oktober 2012
Primärt slutförande (Faktisk)
1 januari 2013
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
9 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
9 oktober 2012
Första postat (Uppskatta)
12 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1220.53
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