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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Ranitidine + Tiotropium

Drug: Cimetidine + Tiotropium

Drug: Tiotropium

Study type

Interventional

Funder types

Industry

Identifiers

NCT02172417

205.222

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

50 to 65 years old

Volunteers

Accepts Healthy Volunteers

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