Telmisartan, Amlodipine and Combination in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: amlodipine/telmisartan/combination

• Registration Number: NCT01181011
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-10
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2010-11
• Results First Submitted: 2011-11-21
• Results First Submitted QC: 2012-04-12
• Results First Posted: 2012-05-10
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
amlodipine/telmisartan/combination	amlodipine/telmisartan/combination	all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order

Primary Outcome Measures

Name	Time	Method
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)	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-∞ of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Cmax of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs
The Maximum Observed Plasma Concentration (Cmax) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
AUC_0-tz of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Secondary Outcome Measures

Name	Time	Method
Time to Attain Cmax (Tmax) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Terminal Rate Constant in Plasma (λz) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs	reflect the speed of drug elimination in vivo
Elimination Half-life (t_½) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
λz of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
V_z/F of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
MRT_po of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Number of Participants With at Least One Treatment Emergent Adverse Event	4 weeks
Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities	4 weeks
Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
Tmax of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
t_½ of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs
CL/F of Amlodipine	3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs

Trial Locations

Locations (1)

1235.30.86001 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China