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

Condition(s) targeted: Healthy

Intervention: Telmisartan/Amlodipine (Drug); Telmisartan (Drug); Amlodipine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Official title: Bioequivalence of 40 mg Telmisartan/5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers. An Open-label, Randomised, Single-dose, Two-period Crossover Study

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

Primary outcome:

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

Maximum measured concentration of the analyte in plasma (Cmax)

Secondary outcome:

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 (AUC0-tz)

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

Terminal rate constant in plasma (λz)

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

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

Apparent clearance of the analyte in plasma after p.o. administration (CL/F)

apparent volume of distribution during the terminal phase λz after p.o. administration (Vz/F)

Number of subjects with adverse events

Assessment of tolerability by investigator on a 4-point scale

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

Criteria:

Inclusion Criteria: 1. 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 2. Age ≥18 and Age ≤55 years 3. BMI ≥18. 5 and BMI ≤29. 9 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation Exclusion Criteria: 1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 6. History of relevant orthostatic hypotension, fainting spells or blackouts 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 9. 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 10. 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 11. Participation in another trial with an investigational drug within two months prior to administration or during the trial 12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) 13. Inability to refrain from smoking during 24 hours prior to dosing and during the trial 14. Alcohol abuse or inability to stop alcoholic beverages for 24 hours prior to dosing and during the trial 15. Drug abuse 16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 17. Excessive physical activities (within one week prior to administration or during the trial) 18. Any laboratory value outside the reference range that is of clinical relevance 19. Any history of relevant low blood pressure 20. Supine blood pressure at screening of systolic <110 mm Hg and diastolic <60 mm Hg 21. History of urticaria 22. History of angioneurotic edema 23. Fructose intolerance For female subjects: 24. Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion 25. 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) 26. Lactation period

Starting date: September 2007
Last updated: October 6, 2014