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Completed

NCT Number: NCT01290757

Bioequivalence of Two Different Capsule Types of Dabigatran

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.

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1160.117.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran Etexilate

Drug

150 mg Capsugel (T)

Primary outcomes

  1. Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran

    Time frame: 60 hours

    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.

  2. Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma

    Time frame: 60 hours

    Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.

Secondary outcomes

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

    Time frame: 60 hours

    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.

  2. AUC0-tz of Free Dabigatran.

    Time frame: 60 hours

    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.

  3. Cmax of Free Dabigatran in Plasma.

    Time frame: 60 hours

    Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.

  4. AUC0-∞ of Free Dabigatran.

    Time frame: 60 hours

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Bioequivalence of Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 7, 2011
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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