Clinical trial NCT01181011: Telmisartan, Amlodipine and Combination in Healthy 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: The Maximum Observed Plasma Concentration (Cmax) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: AUC_0-tz of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: AUC_0-∞ of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Cmax of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs
Secondary outcomes:
measure: Time to Attain Cmax (Tmax) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Terminal Rate Constant in Plasma (λz) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Elimination Half-life (t_½) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Tmax of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: λz of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: MRT_po of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: t_½ of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: CL/F of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: V_z/F of Amlodipine
timeFrame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
measure: Number of Participants With at Least One Treatment Emergent Adverse Event
timeFrame: 4 weeks
measure: Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 1235.30.86001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: