Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

NCT02171520 | Completed Phase 1

• 1 other identifier: 1160.70
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches. The test batch was the drug product batch intended for future commercial use.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-infinity (area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

• Cmax (maximum measured concentration of total dabigatran in plasma)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

Secondary Outcomes (10)

• AUC0-infinity (area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

• Cmax (maximum measured concentration of free dabigatran in plasma)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

• AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 with t1 = 0 and t2 = 24, 48, 72 hours)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  before drug administration and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours following drug administration

Study Arms (2)

Dabigatran etexilate generation I

EXPERIMENTAL

Drug: Dabigatran etexilate generation I

Dabigatran etexilate generation II

ACTIVE COMPARATOR

Drug: Dabigatran etexilate generation II

Interventions

Dabigatran etexilate generation I DRUG

Dabigatran etexilate generation I

Dabigatran etexilate generation II DRUG

Dabigatran etexilate generation II

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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, pulse rate), 12-lead electrocardiogram, clinical laboratory tests
• Age ≥60 and ≤85 years
• Body mass index (BMI) ≥18.5 and BMI ≤30.0 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with 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
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Any relevant bleeding history
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• 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
• Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
• Alcohol abuse (more than 60 g/day for men and more than 40 g/day for woman)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance (especially hemoglobin and activated partial thromboplastin time) or positive drug or virus screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: June 24, 2014

Record last verified: 2014-06