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

• ClinicalTrials.gov Identifier: NCT02183675
• Recruitment Status: Completed
• First Posted: July 8, 2014
• Results First Posted: November 30, 2016
• Last Update Posted: November 30, 2016
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Telmisartan/Amlodipine; Drug: Telmisartan/Amlodipine/HCTZ; Drug: Telmisartan/HCTZ	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: July 2014
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: T/A/H; Telmisartan/Amlodipine/HCTZ fixed-dose combination	Drug: Telmisartan/Amlodipine/HCTZ; Telmisartan/Amlodipine/HCTZ fixed-dose combination
Active Comparator: T/A; Telmisartan/Amlodipine fixed-dose combination	Drug: Telmisartan/Amlodipine; Telmisartan/Amlodipine fixed-dose combination
Active Comparator: T/H; Telmisartan/HCTZ fixed-dose combination	Drug: Telmisartan/HCTZ; Telmisartan/HCTZ fixed-dose combination

Outcome Measures

Primary Outcome Measures :

1. Maximum Measured Concentration (Cmax) at Steady State for Telmisartan [ Time Frame: 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
2. Area Under the Plasma Concentration Curve at Steady State for Telmisartan [ Time Frame: 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
3. Maximum Measured Concentration (Cmax) at Steady State for Amlodipine [ Time Frame: 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
4. Area Under the Plasma Concentration Curve at Steady State for Amlodipine [ Time Frame: 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
5. Maximum Measured Concentration (Cmax) at Steady State for HCTZ [ Time Frame: 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
6. Area Under the Plasma Concentration Curve at Steady State for HCTZ [ Time Frame: 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 :

1. Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Japan

1348.5.001 Boehringer Ingelheim Investigational Site

Kanagawa , Yokohama, Japan

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02183675
• Other Study ID Numbers: 1348.5
• First Posted: July 8, 2014
• Results First Posted: November 30, 2016
• Last Update Posted: November 30, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Amlodipine; Telmisartan; Hydrochlorothiazide; Telmisartan amlodipine combination; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Diuretics; Natriuretic Agents; Sodium Chloride Symporter Inhibitors