Telmisartan and Amlodipine Versus Monocomponent Tablets

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan/Amlodipine Combination Tablet; Drug: Amlodipine Monocomponent

• Registration Number: NCT01278797
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co. KGs 80 mg telmisartan/10 mg amlodipine fixed dose combination tablet to the corresponding mono-component amlodipine tablets, 10 mg (Pfizers Norvasc).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-17
• Study First Submitted QC: 2011-01-17
• Study First Posted: 2011-01-19
• Primary Completion: 2011-02
• Results First Submitted: 2012-02-13
• Results First Submitted QC: 2012-02-13
• Results First Posted: 2012-03-16
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-28

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
Telmisartan/Amlodipine Fixed Dose	Telmisartan/Amlodipine Combination Tablet	Telmisartan/Amlodipine medium fixed dose combination tablet once daily.
Amlodipine Monocomponent	Amlodipine Monocomponent	Amlodipine Monocomponent 10mg tablet once daily

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Amlodipine	Day 1, Day 22
Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)	Day 1, Day 22	Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method

Secondary Outcome Measures

Name	Time	Method
Time of Maximum Concentration of Amlodipine (TMAX)	Day 1, Day 22	Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period

Trial Locations

Locations (1)

1235.41.0001 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada