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

NCT02176512 | Completed Phase 1

• 1 other identifier: 502.136
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• AUC0-∞ (total area under the plasma drug concentration-time curve from time zero to infinity)

  up to 96 hours post-dose

• Cmax (maximum drug plasma concentration)

  up to 96 hours post-dose

• Amount of Hydrochlorothiazide (HCTZ) excreted in urine over 48 hours (Ae(0-48h))

  0-6, 6-12, 12-24, 24-32, 32-48 hours post-dose

Secondary Outcomes (6)

• tmax (time to achieve Cmax)

  up to 96 hours post-dose

• t1/2 (apparent terminal elimination half-life)

  up to 96 hours post-dose

• CLtot/f (total clearance of a drug from plasma, divided by bioavailability)

  up to 96 hours post-dose

• MRTtot (mean time of residence of drug molecules in the body)

  up to 96 hours post-dose

• Vz/f (apparent volume of distribution during terminal phase)

  up to 96 hours post-dose

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

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

Sequence 2

ACTIVE COMPARATOR

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

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

Interventions

BIBR 277 SE and HCTZ DRUG

Treatment A - fixed dose combination

Sequence 1; Sequence 2

BIBR 277 SE DRUG

Treatment B - Monocomponent

Sequence 1; Sequence 2

HCTZ DRUG

Treatment B -Monocomponent

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: September 1, 1998
• Primary Completion: October 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-07