Relative Bioavailability of Telmisartan and SR26334 After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After Administration of Telmisartan and Clopidogrel Alone in Healthy Male and Female Subjects

Condition(s) targeted: Healthy

Intervention: Telmisartan (Drug); Clopidogrel (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Study to investigate the relative bioavailability of concomitant administration of clopidogrel and telmisartan (Test 1) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2). And to investigate the bioavailability of SR26334 following administration of clopidogrel 30 minutes after intake of telmisartan (Test 2) relative to the bioavailability of SR26334 alone (Reference 1), and relative to the bioavailability of telmisartan alone (Reference 2)

Official title: Relative Bioavailability of Telmisartan and SR26334, the Main Metabolite of Clopidogrel, After Co-administration Compared to the Bioavailability of Telmisartan and SR26334 After p.o. Administration of 80 mg Telmisartan and 75 mg Clopidogrel Alone. A Four-way, Single Dose, Open, Randomised Crossover Study in 24 Healthy Male and Female Subjects

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Cmax (maximum concentration of the analyte in plasma)

Secondary outcome:

Number of subjects with adverse events

Number of subjects with clinically significant findings in vital signs

Number of subjects with clinically significant findings in ECG

Number of subjects with clinically significant findings in labortory test

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

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

λz (terminal rate constant in plasma)

t1/2 (terminal half-life of the analytes in plasma)

MRTpo (mean residence time of the analytes in the body after po administration)

CL/F (apparent clearance of the analytes in the plasma after extravascular administration)

Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

CLR, 0-24 (renal clearance of SR26334 in plasma from the time point t1 until the time point t2)

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and female subjects according to the following criteria: based upon a

complete medical history, the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests

- Signed and dated written informed consent prior to admission to the study in

accordance with Good Clinical Practice (GCP) and local legislation

- Age >= 40 years

- Body Mass Index (BMI) >=18. 5 and <=29. 9 kg/m2

- Good venous status of forearms

Exclusion Criteria:

- Any finding of the medical examination (including blood pressure, heart rate, and

electrocardiogram) deviating from normal and of clinical relevance

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic

or hormonal disorders

- Surgery of gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or

neurological disorders

- History of relevant orthostatic hypotension, fainting spells or blackouts

- Chronic or relevant acute infections

- History of an 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 any 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 two months prior

to administration or during the trial

- Smoker (more than 10 cigarettes or three cigars or three pipes/day)

- Alcohol abuse (more than 60 g/day)

- Drug abuse

- Blood donation or loss of more than 400 mL within four weeks prior to administration

or during the trial.

- Excessive physical activities (within five days prior to administration or during the

trial)

- Any laboratory value outside the reference range of clinical relevance

- History of hereditary fructose intolerance

- Veins unsuited for i. v. puncture on either arm (e. g. veins which are difficult to

locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)

- Inability to comply with the dietary regimen of study centre

- Inability to comply with the investigators instructions

For female subjects:

- Pregnancy

- Positive pregnancy test

- No adequate contraception e. g. oral contraceptives, sterilization, intrauterine

device (IUD)

- Inability to maintain this adequate contraception during the whole study period

- Lactation period

Starting date: April 2004
Last updated: October 10, 2014