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

NCT02121535 | Completed Phase 1 Results

• 1 other identifier: 1348.3
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• AUC0-∞ for Telmisartan

  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

  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

  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

Study Arms (2)

T80/A5/H12.5 mg FDC

EXPERIMENTAL

A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet

Drug: T80/A5 mg FDC tablet; Drug: H12.5 mg tablet; Drug: T80/A5/H12.5 mg FDC tablet

T80/A5 mg FDC+H12.5 mg mono

ACTIVE COMPARATOR

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; Drug: T80/A5/H12.5 ng FDC tablet; Drug: H12.5 mf tablet

Interventions

T80/A5 mg FDC tablet DRUG

T80/A5/H12.5 mg FDC

H12.5 mg tablet DRUG

T80/A5/H12.5 mg FDC

T80/A5/H12.5 ng FDC tablet DRUG

A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet

T80/A5 mg FDC+H12.5 mg mono

H12.5 mf tablet DRUG

A HCTZ 12.5 mg tablet

T80/A5 mg FDC+H12.5 mg mono

T80/A5/H12.5 mg FDC tablet DRUG

T80/A5/H12.5 mg FDC

Eligibility Criteria

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

You may qualify if:

• 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.

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)

Boehringer Ingelheim Investigational Site

Kanagawa, Yokohama, Japan

Location

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

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: April 22, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 12, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-03

Locations

JP (1)