Bioequivalence of Two Different Capsule Types of Dabigatran

NCT01290757 | Completed Phase 1 Results

• 2 other identifiers: 1160.1172010-022966-28
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.

  60 hours

• AUC0-tz of Free Dabigatran.

  60 hours

• Cmax of Free Dabigatran in Plasma.

  60 hours

• AUC0-∞ of Free Dabigatran.

  60 hours

Study Arms (2)

Dabigatran etexilate 150 mg (T)

EXPERIMENTAL

Capsugel (T), oral administration

Drug: Dabigatran etexilate

Dabigatran etexilate 150 mg (R)

EXPERIMENTAL

Qualicaps (R), oral administration

Drug: Dabigatran etexilate

Interventions

Dabigatran etexilate DRUG

150 mg Capsugel (T)

Dabigatran etexilate 150 mg (T)

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1160.117.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 7, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Last Updated: May 19, 2014
• Results First Posted: June 29, 2012

Record last verified: 2013-12

Locations

DE (1)