Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Telmisartan/Amlodipin FDC; Drug: Telmisartan; Drug: Amlodipin

• Registration Number: NCT01344629
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

Detailed Description

Purpose:

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2011-07
• Results First Submitted: 2012-07-10
• Results First Submitted QC: 2012-08-24
• Results First Posted: 2012-08-27
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Telmisartan80mg/Amlodipin5mg FDC	Telmisartan/Amlodipin FDC	single-dose, four-period replicated crossover design
Telmisartan80mgtab + Amlodipin5mg tab	Amlodipin	single-dose, four-period replicated crossover design
Telmisartan80mgtab + Amlodipin5mg tab	Telmisartan	single-dose, four-period replicated crossover design

Primary Outcome Measures

Name	Time	Method
AUC0-tz	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	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
Cmax	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	maximum measured concentration of Telmisartan in plasma

Secondary Outcome Measures

Name	Time	Method
AUC0-∞	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity
λz	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	terminal rate constant of Telmisartan in plasma
MRTpo	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	mean residence time of Telmisartan in the body after oral administration
Tmax	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	time from dosing to the maximum concentration of Telmisartan in plasma
t1/2	Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration	terminal half-life of Telmisartan in plasma

Trial Locations

Locations (1)

1235.28.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Kumamoto, Kumamoto, Japan