Status:
COMPLETED
Telmisartan, Amlodipine and Combination in Healthy Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 interac...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Healthy males and females
- Aged between 18 and 45 years
- Body weight more than 50Kg , and Body Mass Index (BMI ) between 19 and 24 kg/m2
- Exclusion criteria
- Any finding of the medical examination 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 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
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker
- 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
- Inability to comply with dietary regimen of trial site
- A history of additional risk factors for torsade de pointes
- 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 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01181011
Start Date
August 1 2010
Last Update
July 24 2014
Active Locations (1)
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1
1235.30.86001 Boehringer Ingelheim Investigational Site
Shanghai, China