Telmisartan, Amlodipine and Combination in Healthy Subjects

Condition(s) targeted: Healthy

Intervention: amlodipine/telmisartan/combination (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects. To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects. To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.

Official title: A Single-centre, Randomized, Open-label, Three-period Crossover Pharmacokinetic Study of 80 mg Telmisartan / 5 mg Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Chinese Subjects

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

Primary outcome:

Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)

Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan

The Maximum Observed Plasma Concentration (Cmax) of Telmisartan

AUC_0-tz of Amlodipine

AUC_0-∞ of Amlodipine

Cmax of Amlodipine

Secondary outcome:

Time to Attain Cmax (Tmax) of Telmisartan

Terminal Rate Constant in Plasma (λz) of Telmisartan

Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)

Elimination Half-life (t_½) of Telmisartan

Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)

Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan

Tmax of Amlodipine

λz of Amlodipine

MRT_po of Amlodipine

t_½ of Amlodipine

CL/F of Amlodipine

V_z/F of Amlodipine

Number of Participants With at Least One Treatment Emergent Adverse Event

Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion criteria 1. Healthy males and females 2. Aged between 18 and 45 years 3. Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2 Exclusion criteria 1. Any finding of the medical examination 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 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 10. Use of drugs which might reasonably influence the results of the trial 11. Participation in another trial with an investigational drug within two months prior to administration or during the trial 12. Smoker 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. Inability to comply with dietary regimen of trial site 20. A history of additional risk factors for torsade de pointes 21. Any history of relevant low blood pressure 22. Supine blood pressure at screening of systolic <110 mm Hg and diastolic < 60 mm Hg 23. History of urticaria 24. History of angioneurotic edema 25 Pregnancy / positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion 26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period

1235.30.86001 Boehringer Ingelheim Investigational Site, Shanghai, China

Synopsis

Starting date: August 2010
Last updated: July 15, 2014