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The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | Test - Reference - Reference - Test |
|
| Treatment sequence 2 | Experimental | Reference - Test - Test - Reference |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 NA 120 mg capsule | Drug | 1capsule of BI 201335 NA 120 mg capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) | 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 |
| Maximum Measured Concentration (Cmax) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | 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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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.53.08101 Boehringer Ingelheim Investigational Site | Sumida-ku,Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | Treatment sequence: Test - Reference - Reference - Test Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast. Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast. Treatments were separated by a washout period of at least 14 days. |
| FG001 | Treatment Sequence 2 | Treatment sequence: Reference - Test - Test - Reference Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast. Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast. Treatments were separated by a washout period of at least 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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Treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 | Treatment sequence: Test - Reference - Reference - Test Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast. Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast. Treatments were separated by a washout period of at least 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
Four treatment periods (Period 1 to 4) of 6 days for each (Days -1 to 5) + Washout period of at least 14 days between treatments
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product: Faldaprevir 40 mg x 3 Capsules | Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| BI 201335 NA 120 mg capsule |
| Drug |
1 capsule of BI 201335 NA 120 mg capsule |
|
| BI 201335 NA 40 mg capsule | Drug | 3 capsules of BI 201335 NA 40 mg capsule |
|
| BI 201335 NA 40 mg capsule | Drug | 3 capsules of BI 201335 NA 40 mg capsule |
|
| Time From Dosing to the Maximum Measured Concentration (Tmax) | 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 |
| Terminal Rate Constant (λz) | 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 |
| Terminal Half-life (t1/2) | 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 |
| Mean Residence Time (MRTpo) | 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Treatment Sequence 2 | Treatment sequence: Reference - Test - Test - Reference Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast. Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast. Treatments were separated by a washout period of at least 14 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Reference Product: Faldaprevir 120 mg x 1 Capsule | Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| Secondary | Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| Secondary | Time From Dosing to the Maximum Measured Concentration (Tmax) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Mean | Standard Deviation | hours | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| Secondary | Terminal Rate Constant (λz) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| Secondary | Terminal Half-life (t1/2) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| Secondary | Mean Residence Time (MRTpo) | 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. | Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | Observations | Participants |
|
|
|
|
| 0 |
| 59 |
| 7 |
| 59 |
| EG001 | Reference Product: Faldaprevir 120 mg x 1 Capsule | Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast | 0 | 60 | 8 | 60 |
| Gastroenteritis | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |