Overview

Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose combination versus its monocomponents given concurrently
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Ramipril
Telmisartan
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