Dose Tolerance Study in Healthy Male Volunteers After Int... | NCT02260037

NCT02260037

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Epinastine nasal	Experimental	single rising doses	Drug: Epinastine nasal
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Epinastine nasal	Drug		Epinastine nasal
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with clinically relevant findings in vital signs	blood pressure, pulse rate	up to 8 days after drug administration
Number of patients with clinically relevant findings in 12-lead ECG		up to 8 days after drug administration
Number of patients with adverse events		up to 8 days after drug administration
Number of patients with clinically relevant findings in laboratory parameters		up to 8 days after drug administration
Changes in rhinoscopy assessment		up to 8 days after drug administration

Secondary Outcomes

Measure	Description	Time Frame
Maximum measured concentration in plasma (Cmax)		up to 48 hours after drug administration
Time from dosing to the maximum concentration in plasma (tmax)		up to 48 hours drug administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All participants in the study should be healthy, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca -Index)
Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG. Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscientia Ingelheim, Germany). The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

Any finding of the medical examination (including blood pressure, pulse rate and ECG) 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 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 drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during the trial)
Participation in another trial with an investigational drug (≤ 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 trial days
Alcohol abuse (> 60 g/day)
Drug abuse
Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
Excessive physical activities (within the last week before the study)
Any laboratory value outside the reference range of clinical relevance