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

Study Overview
=================
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.

Official Title
-----------------
Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet and Hydrochlorothiazide 12.5 mg Tablet in Healthy Male Subjects : an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: T80/A5 mg FDC tablet
* Drug: T80/A5 mg FDC tablet
* Drug: H12.5 mg tablet
* Drug: T80/A5/H12.5 ng FDC tablet
* Drug: H12.5 mf tablet
* Drug: T80/A5/H12.5 mg FDC tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male subjects age =20 and =35 years; body weight: =50 kg and =80 kg; body mass index: =18.0 and =25.0 kg/m2 Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation. Exclusion criteria: - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T80/A5/H12.5 mg FDC<br>A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet | Drug: T80/A5 mg FDC tablet<br> <br> Drug: H12.5 mg tablet<br> <br> Drug: T80/A5/H12.5 mg FDC tablet<br> <br> |
| Active Comparator: T80/A5 mg FDC+H12.5 mg mono<br>A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet | Drug: T80/A5 mg FDC tablet<br>* A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet<br>Drug: T80/A5/H12.5 ng FDC tablet<br>* A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet<br>Drug: H12.5 mf tablet<br>* A HCTZ 12.5 mg tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 
| Cmax for Telmisartan | Cmax (maximum measured concentration of the analyte in plasma) | 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-tz for Amlodipine | 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) | 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration | 
| Cmax for Amlodipine | Cmax (maximum measured concentration of the analyte in plasma) | 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration | 
| Cmax for Hydrochlorothiazide | Cmax (maximum measured concentration of the analyte in plasma) | 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 for Hydrochlorothiazide | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ for Telmisartan | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 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-∞ for Amlodipine | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration | 
| AUC0-∞ for Hydrochlorothiazide | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 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 |