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

NCT ID: NCT02262572

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan /HCTZ - compression tablet (DC)

Group Type: EXPERIMENTAL

Telmisartan /HCTZ - compression tablet (DC)

Intervention Type: DRUG

Telmisartan /HCTZ - dry granulation tablet (DG)

Group Type: EXPERIMENTAL

Telmisartan /HCTZ - dry granulation tablet (DG)

Intervention Type: DRUG

Telmisartan /HCTZ - present commercial formulation

Group Type: ACTIVE_COMPARATOR

Telmisartan /HCTZ - present commercial formulation

Intervention Type: DRUG

Interventions

Telmisartan /HCTZ - compression tablet (DC)

Intervention Type: DRUG

Telmisartan /HCTZ - dry granulation tablet (DG)

Intervention Type: DRUG

Telmisartan /HCTZ - present commercial formulation

Intervention Type: DRUG

Other Intervention Names

MicardisPlus®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.415

Identifier Type: -

Identifier Source: org_study_id