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

NCT02171013 | Completed Phase 1

• 1 other identifier: 1160.56
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 72 hours after drug administration

• Maximum measured concentration of total BIBR 953 ZW in plasma (Cmax)

  Up to 72 hours after drug administration

Secondary Outcomes (16)

• Area under the concentration-time curve of free BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 72 hours after drug administration

• Maximum measured concentration of free BIBR 953 ZW in plasma (Cmax)

  Up to 72 hours after drug administration

• 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 (AUC0-tz)

  Up to 72 hours after drug administration

• Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2 (AUCt1-t2)

  t1 = 0 and t2 = 24, 48, 72 hours after drug administration

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

  Up to 72 hours after drug administration

Study Arms (2)

Dabigatran etexilate batch A

EXPERIMENTAL

Drug: Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)

Dabigatran etexilate batch B

EXPERIMENTAL

Drug: Dabigatran polymorph I

Interventions

Dabigatran polymorph I DRUG

Dabigatran etexilate batch B

Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%) DRUG

Dabigatran etexilate batch A

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 (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥65 and ≤85 years
• BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
• 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)
• 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

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 23, 2014
• Study Start: April 1, 2006
• Primary Completion: July 1, 2006
• Last Updated: June 23, 2014

Record last verified: 2014-06