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Bioequivalence of Telmisartan / Ramipril Fixed Dose Combination Compared With the Monocomponents Given Concomitantly to Healthy Male and Female Volunteers

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Telmisartan/Ramipril (Drug); Telmisartan (Drug); Ramipril capsule (Drug); Ramipril tablet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2. 5 mg ramipril fixed-dose combination (FDC) versus its monocomponents given concomitantly

Clinical Details

Official title: Bioequivalence of 40 mg Telmisartan / 2.5 mg Ramipril Fixed Dose Combination Compared With the Monocomponents, Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Three-way Crossover Study)

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

Primary outcome:

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

Cmax (maximum measured concentration of the analyte in plasma)

Secondary outcome:

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)

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

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

λz (terminal rate constant in plasma)

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

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

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

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

Number of patients with adverse events

Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate)

Number of patients with clinically relevant changes in laboratory tests

Number of patients with clinically relevant changes in 12-lead electrocardiogram

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy males and females according to the following criteria based upon a complete

medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

- Age ≥18 and Age ≤55 years

- BMI ≥18. 5 and BMI ≤29. 9 kg/m2 (Body Mass Index)

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

accordance with Good Clinical Practice and the local legislation Exclusion Criteria:

- Any finding of the medical examination (including BP, PR and ECG) deviating from

normal and of clinical relevance

- Any evidence of a clinically relevant concomitant disease

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

immunological or hormonal disorders

- Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its

excipients)

- 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 (especially

unspecific inducing agents like St. John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval 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 (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

- Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after

dosing

- Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24

hours prior to dosing and up to the last sampling time point, 96 hours after dosing.

- 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

- Inability to comply with dietary regimen of trial site

- A marked baseline prolongation of QT/QTc interval (e. g., repeated demonstration of a

QTc interval >450 ms)

- A history of additional risk factors for torsade de pointes (e. g., heart failure,

hyperkalemia, hypokalemia, family history of Long QT Syndrome)

- Any history of relevant low blood pressure

- Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg

- History of urticaria

- History of angioneurotic edema

- Hereditary fructose intolerance

For female subjects:

- Pregnancy or planning to become pregnant during the study or within 2 months of study

completion

- Positive pregnancy test

- Are not willing or are unable to use a reliable method of contraception (such as

implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial

- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol

as the only method of contraception

- Currently lactating

Locations and Contacts

Additional Information

Starting date: March 2007
Last updated: August 12, 2014

Page last updated: August 23, 2015

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