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

NCT ID: NCT02261077

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Buscopan, single rising doses

Group Type: EXPERIMENTAL

Hyoscine butylbromide

Intervention Type: DRUG

Buscopan, multiple rising doses

Group Type: EXPERIMENTAL

Hyoscine butylbromide

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Hyoscine butylbromide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Buscopan®

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202.833

Identifier Type: -

Identifier Source: org_study_id