Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: T80/A5 mg FDC tablet; Drug: T80/A5/H12.5 ng FDC tablet; Drug: H12.5 mg tablet; Drug: T80/A5/H12.5 mg FDC tablet; Drug: H12.5 mf tablet

• Registration Number: NCT02121535
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2016-10-06
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Results First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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
T80/A5 mg FDC+H12.5 mg mono	T80/A5/H12.5 ng FDC tablet	A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
T80/A5/H12.5 mg FDC	T80/A5/H12.5 mg FDC tablet	A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet
T80/A5/H12.5 mg FDC	T80/A5 mg FDC tablet	A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet
T80/A5 mg FDC+H12.5 mg mono	T80/A5 mg FDC tablet	A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
T80/A5 mg FDC+H12.5 mg mono	H12.5 mf tablet	A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet
T80/A5/H12.5 mg FDC	H12.5 mg tablet	A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet

Primary Outcome Measures

Name	Time	Method
AUC0-tz for Amlodipine	3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration	AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Cmax for Telmisartan	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration	Cmax (maximum measured concentration of the analyte in plasma)
Cmax for Amlodipine	3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration	Cmax (maximum measured concentration of the analyte in plasma)
AUC0-tz for Hydrochlorothiazide	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration	AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration	Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Cmax for Hydrochlorothiazide	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration	Cmax (maximum measured concentration of the analyte in plasma)

Secondary Outcome Measures

Name	Time	Method
AUC0-∞ for Telmisartan	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration	AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
AUC0-∞ for Amlodipine	3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration	AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
AUC0-∞ for Hydrochlorothiazide	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration	AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Kanagawa, Yokohama, Japan