Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Hyoscine butylbromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261077

202.833

Details and patient eligibility

About

Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses

Enrollment: 60 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
2. Age ≥21 and age ≤50 years
3. BMI ≥18.5 and BMI <30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
8. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to randomization
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
10. Participation in another trial with an investigational drug within two months prior to randomization
11. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (more than 40 g/day for males)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities within one week prior to administration or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of trial site
19. Hypersensitivity to hyoscine butylbromide and/or related drugs of these classes
20. History of megacolon
21. History of prostatic hyperplasia
22. History of mechanical stenosis of the gastrointestinal (e.g. after surgery of the gastrointestinal tract)
23. History of narrow-angle glaucoma
24. History of tachycardic arrhythmias
25. History of myasthenia gravis
26. Bladder-neck obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Buscopan, single rising doses

Experimental group

Treatment:

Drug: Hyoscine butylbromide

Buscopan, multiple rising doses

Experimental group

Treatment:

Drug: Hyoscine butylbromide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo