1235.30.86001 Boehringer Ingelheim Investigational Site
Shanghai, China
NCT Number: NCT01181011
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
reflect the speed of drug elimination in vivo
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Time frame: 4 weeks
Time frame: 4 weeks
Boehringer Ingelheim
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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