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

NCT02183675 | Completed Phase 1 Results

• 1 other identifier: 1348.5
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• 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

Study Arms (3)

T/A/H

EXPERIMENTAL

Telmisartan/Amlodipine/HCTZ fixed-dose combination

Drug: Telmisartan/Amlodipine/HCTZ

T/A

ACTIVE COMPARATOR

Telmisartan/Amlodipine fixed-dose combination

Drug: Telmisartan/Amlodipine

T/H

ACTIVE COMPARATOR

Telmisartan/HCTZ fixed-dose combination

Drug: Telmisartan/HCTZ

Interventions

Telmisartan/Amlodipine DRUG

Telmisartan/Amlodipine fixed-dose combination

T/A

Telmisartan/Amlodipine/HCTZ DRUG

Telmisartan/Amlodipine/HCTZ fixed-dose combination

T/A/H

Telmisartan/HCTZ DRUG

Telmisartan/HCTZ fixed-dose combination

T/H

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1348.5.001 Boehringer Ingelheim Investigational Site

Kanagawa , Yokohama, Japan

Location

MeSH Terms

Interventions

telmisartan amlodipine combination; Telmisartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 30, 2016
• Results First Posted: November 30, 2016

Record last verified: 2016-10

Locations

JP (1)