NCT02129192

Brief Summary

To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

April 30, 2014

Results QC Date

October 6, 2016

Last Update Submit

March 1, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Maximum Measured Concentration (Cmax) of the Analytes in Plasma

    Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

  • Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet

    Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

  • Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration

    Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

  • Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet

    Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

Secondary Outcomes (2)

  • Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

  • Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet

    3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only

Study Arms (2)

T80/A5/H12.5 mg FDC

EXPERIMENTAL

Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet

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

T80/H12.5 FDC + A5 mono

ACTIVE COMPARATOR

Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule

Drug: Amlodipine 5mg capsuleDrug: T80/H12.5 mg FDC tablet

Interventions

Amlodipine 5mg capsuleDRUG

Amlodipine 5mg capsule

T80/H12.5 FDC + A5 mono
T80/H12.5 mg FDC tabletDRUG

Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet

T80/H12.5 FDC + A5 mono
T80/A5/H12.5 mg FDC tabletDRUG

Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet

T80/A5/H12.5 mg FDC

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Investigational Site

Tokyo, Hachioji, Japan

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic 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

April 30, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

April 12, 2017

Results First Posted

April 12, 2017

Record last verified: 2017-03

Locations

JP(1)