Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Amlodipine

Drug: Telmisartan

Drug: Telmisartan/Amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02259829

1235.3

Details and patient eligibility

About

Study to demonstrate the bioequivalence of 40 mg telmisartan / 5 mg amlodipine fixed dose combination vs. its monocomponents

Enrollment

84 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead 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 except for oral contraceptives as well as ovary and thyroid hormone replacement
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/corrected QT 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 during the trial
Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial
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
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
Fructose intolerance

For female subjects:
Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion
No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Lactation period