Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

NCT02710630 | Completed Phase 1 Results

• 1 other identifier: 1160.246
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate. The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

  This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

• Cmax (Maximum Concentration of Free Dabigatran)

  This outcome measure presents maximum concentration of analyte in plasma (Cmax).

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Secondary Outcomes (4)

• AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

• AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

• Cmax (Maximum Plasma Concentration of Total Dabigatran)

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

• AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)

  1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Study Arms (6)

Dabigatran etexilate capsule

ACTIVE COMPARATOR

Drug: Dabigatran etexilate capsule

Dabigatran etexilate tablet A1

EXPERIMENTAL

Drug: Dabigatran etexilate tablet A1

Dabigatran etexilate tablet B1

EXPERIMENTAL

Drug: Dabigatran etexilate tablet B1

Dabigatran etexilate tablet C1

EXPERIMENTAL

Drug: Dabigatran etexilate tablet C1

Dabigatran etexilate tablet D1

EXPERIMENTAL

Drug: Dabigatran etexilate tablet D1

Dabigatran etexilate tablet E1

EXPERIMENTAL

Drug: Dabigatran etexilate tablet E1

Interventions

Dabigatran etexilate tablet E1 DRUG

Dabigatran etexilate tablet E1

Dabigatran etexilate tablet D1 DRUG

Dabigatran etexilate tablet D1

Dabigatran etexilate tablet C1 DRUG

Dabigatran etexilate tablet C1

Dabigatran etexilate tablet B1 DRUG

Dabigatran etexilate tablet B1

Dabigatran etexilate tablet A1 DRUG

Dabigatran etexilate tablet A1

Dabigatran etexilate capsule DRUG

Dabigatran etexilate capsule

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \<=35 years old
• Body mass index (BMI) \>=18.0 and \<=25.0 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP, Pulse Rate, or ECG) deviating from normal and judged as clinically relevant by the investigator at screening
• 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
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any relevant bleeding history considered by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• 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
• 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)
• Any evidence of a concomitant disease considered as clinically relevant by the investigator
• Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
• Intake of medication, which influences the blood clotting, e.g., acetylsalicylic acid, coumarin etc. within 10 days prior to trial medication

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 133-0004, Japan

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

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

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: March 14, 2016
• First Posted: March 17, 2016
• Study Start: March 22, 2016
• Primary Completion: May 11, 2016
• Study Completion: June 10, 2016
• Last Updated: November 6, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-10

Locations

JP (1)