Telmisartan/Hydrochlorothiazide (HCTZ) Fixed Dose Combination Compared to Its Monocomponents in Healthy Subjects

NCT ID: NCT02176512

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

Brief Summary

Study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations

Conditions

Healthy

Study Design

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

Study Groups

Sequence 1

four treatment periods:

1. Treatment A

2. Treatment B

3. Treatment B

4. Treatment A

Group Type: EXPERIMENTAL

BIBR 277 SE and HCTZ

Intervention Type: DRUG

Treatment A - fixed dose combination

BIBR 277 SE

Intervention Type: DRUG

Treatment B - Monocomponent

HCTZ

Intervention Type: DRUG

Treatment B -Monocomponent

Sequence 2

four treatment periods:

1. Treatment B

2. Treatment A

3. Treatment A

4. Treatment B

Group Type: ACTIVE_COMPARATOR

BIBR 277 SE and HCTZ

Intervention Type: DRUG

Treatment A - fixed dose combination

BIBR 277 SE

Intervention Type: DRUG

Treatment B - Monocomponent

HCTZ

Intervention Type: DRUG

Treatment B -Monocomponent

Interventions

BIBR 277 SE and HCTZ

Treatment A - fixed dose combination

Intervention Type: DRUG

BIBR 277 SE

Treatment B - Monocomponent

Intervention Type: DRUG

HCTZ

Treatment B -Monocomponent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects as determined by results of screening
• Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
• Age ≥ 18 and ≤ 45 years
• Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria

• Any findings of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastro-intestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
• History of orthostatic hypotension, fainting spells or blackouts
• Hypersensitivity to Telmisartan and/or HCTZ and/or related classes of drugs
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
• Smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day)
• Inability to refrain from smoking on study days
• Known alcohol abuse
• Known drug abuse
• Blood donation (≤ 1 month prior to administration)
• Excessive physical activities (≤ 5 days prior to administration)
• For female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.136

Identifier Type: -

Identifier Source: org_study_id