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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Telmisartan /HCTZ - compression tablet (DC)

Drug: Telmisartan /HCTZ - dry granulation tablet (DG)

Drug: Telmisartan /HCTZ - present commercial formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02262572

502.415

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 trial)
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