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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBR 277 SE; Drug: BIBR 277 SE and HCTZ; Drug: HCTZ

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176512

502.136

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sequence 1

Experimental group

Description:

four treatment periods: 1. Treatment A 2. Treatment B 3. Treatment B 4. Treatment A

Treatment:

Drug: BIBR 277 SE and HCTZ

Drug: HCTZ

Drug: BIBR 277 SE

Sequence 2

Active Comparator group

Description:

four treatment periods: 1. Treatment B 2. Treatment A 3. Treatment A 4. Treatment B

Treatment:

Drug: BIBR 277 SE and HCTZ

Drug: HCTZ

Drug: BIBR 277 SE