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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Telmisartan/Amlodipine; Drug: Telmisartan/Amlodipine/HCTZ; Drug: Telmisartan/HCTZ

• Registration Number: NCT02183675
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-10
• Results First Submitted: 2016-10-06
• Results First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Results First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T/A	Telmisartan/Amlodipine	Telmisartan/Amlodipine fixed-dose combination
T/A/H	Telmisartan/Amlodipine/HCTZ	Telmisartan/Amlodipine/HCTZ fixed-dose combination
T/H	Telmisartan/HCTZ	Telmisartan/HCTZ fixed-dose combination

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax) at Steady State for Amlodipine	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) of amlodipine in plasma at steady state over the dosing interval tau
Maximum Measured Concentration (Cmax) at Steady State for Telmisartan	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) of telmisartan in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for Telmisartan	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 (AUC) of telmisartan in plasma at steady state over the dosing interval tau
Maximum Measured Concentration (Cmax) at Steady State for HCTZ	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	Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for Amlodipine	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 (AUC) of amlodipine in plasma at steady state over the dosing interval tau
Area Under the Plasma Concentration Curve at Steady State for HCTZ	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 (AUC) of HCTZ in plasma at steady state over the dosing interval tau

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1348.5.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Kanagawa , Yokohama, Japan