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Trial record 28 of 50 for:    BI 201335 OR faldaprevir

Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

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ClinicalTrials.gov Identifier: NCT01704846
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: BI 201335 NA 120 mg capsule Drug: BI 201335 NA 40 mg capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Treatment sequence 1
Test - Reference - Reference - Test
Drug: BI 201335 NA 120 mg capsule
1 capsule of BI 201335 NA 120 mg capsule

Drug: BI 201335 NA 40 mg capsule
3 capsules of BI 201335 NA 40 mg capsule

Experimental: Treatment sequence 2
Reference - Test - Test - Reference
Drug: BI 201335 NA 120 mg capsule
1capsule of BI 201335 NA 120 mg capsule

Drug: BI 201335 NA 40 mg capsule
3 capsules of BI 201335 NA 40 mg capsule




Primary Outcome Measures :
  1. Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: 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.


  2. Maximum Measured Concentration (Cmax) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) [ Time Frame: 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.


  2. Time From Dosing to the Maximum Measured Concentration (Tmax) [ Time Frame: 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. Terminal Rate Constant (λz) [ Time Frame: 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.

  4. Terminal Half-life (t1/2) [ Time Frame: 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.

  5. Mean Residence Time (MRTpo) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male volunteers without any clinical significant findings and complications
  2. Age: 20 - 45 years
  3. BMI: 18.5 - 25.0 kg/m2
  4. Signed informed consent

Exclusion criteria:

  1. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
  2. Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  4. History of jaundice
  5. Surgery of the gastrointestinal tract (except appendectomy).
  6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  7. History of relevant orthostatic hypotension, fainting spells or blackouts.
  8. Chronic or relevant acute infections.
  9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
  10. 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
  11. 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.
  12. Participation in another trial with an investigational drug within two months prior to administration or during the trial.
  13. Smoking (>10 cigarettes or >3 cigars or >3 pipes/day).
  14. Inability to refrain from smoking during the trial.
  15. Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake).
  16. Drug abuse.
  17. Blood donation (more than 100 mL within four weeks prior to administration).
  18. Excessive physical activities (within one week prior to administration).
  19. Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement.
  20. Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704846


Locations
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Japan
1220.53.08101 Boehringer Ingelheim Investigational Site
Sumida-ku,Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01704846     History of Changes
Other Study ID Numbers: 1220.53
First Posted: October 12, 2012    Key Record Dates
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases