Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022966-28 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.
The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate 150 mg (T) | Experimental | Capsugel (T), oral administration |
|
| Dabigatran etexilate 150 mg (R) | Experimental | Qualicaps (R), oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug | 150 mg Capsugel (T) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran | Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | 60 hours |
| Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma | Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | 60 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran. | Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | 60 hours |
| AUC0-tz of Free Dabigatran. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.117.1 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
In this crossover study, subjects were randomly assigned to one of the 2 sequences, with 2 treatment arms. In general terms, Ref-Test-Ref-Test and Test-Ref-Test-Ref. The aim was bioequivalence comparing (Ref) Dabigatran 150mg in the currently approved capsule shell (Qualicaps) to the test of Dabigatran 150mg in a new shell (Capsugel).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel | Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT) |
| FG001 | Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps | Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set includes all patients who received at least one study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel | Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT) |
| BG001 | Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps |
| 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 0 to tz (AUC0-tz) of Total Dabigatran | Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 60 hours |
|
Approximately 7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qualicaps | Dabigatran 150mg in Qualicaps |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dabigatran etexilate |
| Drug |
150 mg Qualicaps (R) |
|
Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. |
| 60 hours |
| Cmax of Free Dabigatran in Plasma. | Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | 60 hours |
| AUC0-∞ of Free Dabigatran. | Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | 60 hours |
| Other |
|
Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR) |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Qualicaps |
Dabigatran 150mg in currently approved Qualicaps |
|
|
|
| Primary | Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma | Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 60 hours |
|
|
|
|
| Secondary | Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran. | Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 60 hours |
|
|
|
|
| Secondary | AUC0-tz of Free Dabigatran. | Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 60 hours |
|
|
|
|
| Secondary | Cmax of Free Dabigatran in Plasma. | Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 60 hours |
|
|
|
|
| Secondary | AUC0-∞ of Free Dabigatran. | Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 60 hours |
|
|
|
|
| 0 |
| 180 |
| 37 |
| 180 |
| EG001 | Capsugel | Dabigatran 150mg in Capsugel | 0 | 180 | 34 | 180 |
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Capsugel vs Qualicaps | Mixed Models Analysis | Adjusted geometric mean ratio (%) | 125.49 | 90 | 118.69 | 132.67 | Yes | Non-Inferiority or Equivalence | Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%). |