Phase 1
N=180
Bioequivalence of Two Different Capsule Types of Dabigatran
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01290757 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran — 1147.64; 908.48 ng*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Dabigatran etexilate (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran |
1147.64; 908.48 | — |
| PRIMARY Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma |
134.44; 107.13 | — |
| SECONDARY Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran. |
1175.05; 941.99 | — |
| SECONDARY AUC0-tz of Free Dabigatran. |
856.31; 678.43 | — |
| SECONDARY Cmax of Free Dabigatran in Plasma. |
106.66; 85.12 | — |
| SECONDARY AUC0-∞ of Free Dabigatran. |
888.86; 714.01 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age =21 and = 55 years
- Body Mass Index (BMI) =18.5 and BMI = 29.9 kg/m^2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion criteria
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Clinically relevant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug
- Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month
- Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy in particular to study drug or its excipients) which is deemed relevant to the trial as judged by the investigator
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Alcohol abuse (more than 20 g/day)
- Drug abuse
- Any laboratory value outside the reference range that is of clinical relevance (especially hemoglobin, thrombocytes, prothrombin time (PT) and Activated Partial Thromboplastin Time (Measure of the clotting time) (aPTT) or positive drug or virus screening
- Planned surgeries within four weeks following the end-of study examination
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding within 14 days before or after end-of study examination
Data sourced from ClinicalTrials.gov (NCT01290757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.