Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03070171
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects
• Scientific title: Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Replicate Design in a Two-treatment, Four-period, Two-sequence Crossover Study)
• Date of first enrolment: March 21, 2017
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03070171
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Key inclusion & exclusion criteria

Inclusion Criteria:

Subjects will only be included into the trial, if they meet the following criteria:

- Healthy male subjects according to the investigator's assessment, based on a complete
medical history including a physical examination, vital signs (blood pressure (BP),
pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

- Age =20 and =40 years old at informed consent

- BMI =18 and =25 kg/m2 at screening

- Signed and dated written informed consent prior to admission to the trial in
accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

Subjects will not be allowed to participate if any of the following general criteria apply:

- Any finding in the medical examination (including blood pressure (BP), pulse rate
(PR)or electrocardiogram (ECG)) is deviating from normal and judged as clinically
relevant by the investigator

- Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic
blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of
45 to 90 bpm at screening. Based on the clinical judge by the investigator, repeated
measurements are allowed.

- Any laboratory value outside the reference range before randomisation that the
investigator considers to be of clinical relevance

- Any evidence of a concomitant disease considered as clinically relevant by the
investigator

- Any relevant bleeding history considered by the investigator

- Any history or evidence of blood dyscrasia, haemorrhagic diathesis, severe
thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with
active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary
tract or any disease or condition with haemorrhagic tendencies

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders

- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)

- Planned surgeries within four weeks following the end-of trial examination

- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders

- History of relevant orthostatic hypotension, fainting spells, or blackouts

- Chronic or relevant acute infections

- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)

- Use of drugs within 30 days prior to administration of trial medication if that might
reasonably influence the results of the trial (incl.Qc/QTc interval prolongation)

- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication, or current
participation in another trial involving administration of investigational drug

- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

- Inability to refrain from smoking in-house confinement at the trial site

- Alcohol abuse (consumption of more than 30 g per day: e.g., 750 mL of beer, 1.5 gous
[equivalent to 270 mL] of Sake)

- Drug abuse or positive drug screening

- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial

- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial

- Inability to comply with dietary regimen of trial site

- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with trial requirements, or has a
condition that would not allow safe participation in the trial



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: dabigatran etexilate

Primary Outcome(s)

AUC0-tz of Free Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

Cmax of Free Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

Secondary Outcome(s)

AUC0-8 of Total Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

Cmax of Total Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

AUC0-tz of Total Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

AUC0-8 of Free Dabigatran [Time Frame: 1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.]

Secondary ID(s)

1160-0271

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03070171