Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers

Study Overview
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Brief Summary
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To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects

Official Title
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Pharmacokinetics of Multiple Oral Doses of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet, Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Telmisartan 80 mg/Amlodipine 5 mg Fixed-dose Combination Tablet at Steady State in Healthy Male Subjects: an Open-label, Randomised, Multiple-dose, Three Treatment, Three-period, Six-sequence Crossover Study

Conditions
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Healthy

Intervention / Treatment
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* Drug: Telmisartan/Amlodipine
* Drug: Telmisartan/Amlodipine/HCTZ
* Drug: Telmisartan/HCTZ


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy Japanese 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
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T/A/H<br>Telmisartan/Amlodipine/HCTZ fixed-dose combination | Drug: Telmisartan/Amlodipine/HCTZ<br>* Telmisartan/Amlodipine/HCTZ fixed-dose combination<br>|
| Active Comparator: T/A<br>Telmisartan/Amlodipine fixed-dose combination | Drug: Telmisartan/Amlodipine<br>* Telmisartan/Amlodipine fixed-dose combination<br>|
| Active Comparator: T/H<br>Telmisartan/HCTZ fixed-dose combination | Drug: Telmisartan/HCTZ<br>* Telmisartan/HCTZ fixed-dose combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Measured Concentration (Cmax) at Steady State for Telmisartan | Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration | 
| Area Under the Plasma Concentration Curve at Steady State for Telmisartan | Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration | 
| Maximum Measured Concentration (Cmax) at Steady State for Amlodipine | Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration | 
| Area Under the Plasma Concentration Curve at Steady State for Amlodipine | Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration | 
| Maximum Measured Concentration (Cmax) at Steady State for HCTZ | Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration | 
| Area Under the Plasma Concentration Curve at Steady State for HCTZ | Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours | Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state | 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10 |