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Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Telmisartan /HCTZ - compression tablet (DC) (Drug); Telmisartan /HCTZ - dry granulation tablet (DG) (Drug); Telmisartan /HCTZ - present commercial formulation (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim


Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)

Clinical Details

Official title: Relative Bioavailability of Telmisartan and HCTZ p.o. (80 mg Telmisartan/12.5 mg HCTZ) in Two Experimental Formulations (Given t.i.d. for One Day Each) Compared to the Standard Formulation 80 mg Telmisartan/12.5 mg HCTZ (MicardisPlus®), Given t.i.d. for One Day in Healthy Female and Male Subjects. A Three-way Crossover, Open, Randomised Study

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Cmax (Maximum measured concentration of the analyte in plasma)

Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)

Secondary outcome:

tmax (Time from dosing to the maximum concentration of the analyte in plasma)

t1/2 (Terminal half-life of the analyte in plasma)

CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)

MRTtot (Total mean residence time)

Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)

Number of subjects with adverse events

Number of subjects with clinically significant findings in vital signs

Number of subjects with clinically significant findings in 12 lead ECG

Investigator's assessment of tolerability on a 4-point scale


Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria: Subjects meeting the following criteria will be eligible for participation in the study:

- Healthy male and female subjects according to the following criteria: based upon a

complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests.

- Laboratory values within a clinically defined reference range

- Signed and dated written informed consent prior to admission to the study in

accordance with Good Clinical Practice (GCP) and local legislation

- Age >=18 and Age <=55 years

- Body mass index (BMI) >=18. 5 and <=29. 9 kg/m2

- Able to communicate well with the investigator and to comply with study requirements

- Good condition of veins

Exclusion Criteria:

- Any finding of the medical examination (including blood pressure, heart rate, and

electrocardiogram) deviating from normal and of clinical relevance

- Supine blood pressure at screening of systolic ≤ 110 mm Hg and diastolic ≤ 60 mmHg

- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic

or hormonal disorders

- Surgery of gastrointestinal tract (except appendectomy)

- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or

neurological disorders

- History of relevant orthostatic hypotension, fainting spells or blackouts

- Chronic or relevant acute infections

- History of an allergy/hypersensitivity (including drug allergy) which is deemed

relevant to the trial as judged by the investigator

- Intake of drugs with a long half-life (> 24 hours) within at least one month or less

than 10 half-lives of the respective drug prior to administration or during the trial

- Use of any drugs, which might reasonably influence the results of the trial based on

the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial

- Participation in another trial with an investigational drug within two months prior

to administration or during the trial

- Smoker (more than 10 cigarettes or three cigars or three pipes/day)

- Alcohol abuse (more than 60 g/day)

- Drug abuse

- Blood donation or loss of more than 400 mL within four weeks prior to administration

or during the trial

- Excessive physical activities (within five days prior to administration or during the


- Any laboratory value outside the reference range of clinical relevance

- History of hereditary fructose intolerance

- Veins unsuited for i. v. puncture on either arm (e. g. veins which are difficult to

locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)

- Inability to comply with the dietary regimen of study centre

- Inability to comply with the investigator's instructions.

For female subjects:

- Pregnancy

- Positive pregnancy test

- No adequate contraception e. g. oral contraceptives, sterilization, intrauterine

device (IUD)

- Inability to maintain this adequate contraception during the whole study period

- Lactation period

Locations and Contacts

Additional Information

Starting date: April 2003
Last updated: October 9, 2014

Page last updated: August 23, 2015

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