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

NCT02261077 | Completed Phase 1

• 1 other identifier: 202.833
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum measured concentration of analyte in plasma (Cmax)

  up to 104 hours after last drug administration

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 104 hours after last drug administration

• Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)

  up to 80 hours after last drug administration

Secondary Outcomes (22)

• Time from dosing to maximum measured concentration (tmax)

  up to 104 hours after last drug administration

• Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)

  up to 32 hours after drug administration

• Terminal rate constant in plasma (λz)

  up to 104 hours after last drug administration

• Terminal half-life of the analyte in plasma (t1/2)

  up to 104 hours after last drug administration

• Mean residence time of the analyte in the body (MRTpo)

  up to 104 hours after last drug administration

Study Arms (3)

Buscopan, single rising doses

EXPERIMENTAL

Drug: Hyoscine butylbromide

Buscopan, multiple rising doses

EXPERIMENTAL

Drug: Hyoscine butylbromide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hyoscine butylbromide DRUG

Also known as: Buscopan®

Buscopan, multiple rising doses; Buscopan, single rising doses

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age ≥21 and age ≤50 years
• BMI ≥18.5 and BMI \<30 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
• 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
• 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
• Participation in another trial with an investigational drug within two months prior to randomization
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days as judged by the investigator
• Alcohol abuse (more than 40 g/day for males)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 10, 2014
• Study Start: May 1, 2007
• Primary Completion: July 1, 2007
• Last Updated: October 10, 2014

Record last verified: 2014-10