Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects

NCT ID: NCT02172417

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31

Brief Summary

Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population

Conditions

Healthy

Study Design

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

Study Groups

Cimetidine + Tiotropium followed by Tiotropium

Group Type: EXPERIMENTAL

Cimetidine + Tiotropium

Intervention Type: DRUG

Tiotropium

Intervention Type: DRUG

Ranitidine + Tiotropium followed by Tiotropium

Group Type: EXPERIMENTAL

Ranitidine + Tiotropium

Intervention Type: DRUG

Tiotropium

Intervention Type: DRUG

Interventions

Cimetidine + Tiotropium

Intervention Type: DRUG

Ranitidine + Tiotropium

Intervention Type: DRUG

Tiotropium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males or females
• Age range from 50 to 65 years
• Within 20% of their normal weight (Broca index)

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, puls rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study or during the study (exclusion: ovarian hormone substitution)
• Use of any drugs which might influence the results of the trial within four weeks prior to administration or during the trial, among these all non-selective β-blockers, cromolyn sodium, nedocromil sodium, oral β-adrenergics or long-acting β-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT® (ipratropium) by oral inhalation or ATROVENT® Nasal Spray
• Participation in another study with an investigational drug within two 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
• Alcohol abuse (> 40 g/day)
• Drug abuse
• Blood donation (≥ 100 ml) within four weeks prior to administration or during the trial
• Excessive physical activities within 5 days prior to administration or during the trial
• Any laboratory value outside the reference range of clinical relevance
• Subjects with known hypersensitivity to anticholinergic drugs
• Subjects with known symptomatic prostatic hypertrophy or disturbed micturition
• Subjects with known narrow-angle glaucoma

In addition for female subjects (if appropriate):

• Pregnancy
• Positive pregnancy test
• No adequate contraception e.g. oral contraceptives, sterilization, intra uterine pessary (IUP)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

205.222

Identifier Type: -

Identifier Source: org_study_id