- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261077
Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers
October 9, 2014 updated by: Boehringer Ingelheim
A Randomised, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Single Rising Oral Doses (20 mg, 60 mg, 100 mg, 200 mg and 400 mg) and Multiple Rising Oral Doses (3 x 20 mg, 3 x 60 mg and 3 x 100 mg Per Day) of Buscopan® in Healthy Male Volunteers
Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Excessive physical activities within one week prior to administration or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Hypersensitivity to hyoscine butylbromide and/or related drugs of these classes
- History of megacolon
- History of prostatic hyperplasia
- History of mechanical stenosis of the gastrointestinal (e.g. after surgery of the gastrointestinal tract)
- History of narrow-angle glaucoma
- History of tachycardic arrhythmias
- History of myasthenia gravis
- Bladder-neck obstruction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Buscopan, single rising doses
|
Other Names:
|
Experimental: Buscopan, multiple rising doses
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum measured concentration of analyte in plasma (Cmax)
Time Frame: up to 104 hours after last drug administration
|
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-∞)
Time Frame: up to 104 hours after last drug administration
|
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)
Time Frame: up to 80 hours after last drug administration
|
up to 80 hours after last drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time Frame: up to 80 hours after last drug administration
|
up to 80 hours after last drug administration
|
Time from dosing to maximum measured concentration (tmax)
Time Frame: up to 104 hours after last drug administration
|
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)
Time Frame: up to 32 hours after drug administration
|
up to 32 hours after drug administration
|
Terminal rate constant in plasma (λz)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Mean residence time of the analyte in the body (MRTpo)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Total/apparent clearance in plasma after extravascular administration (CL/F)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time Frame: up to 80 hours after last drug administration
|
up to 80 hours after last drug administration
|
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time Frame: up to 80 hours after last drug administration
|
up to 80 hours after last drug administration
|
Average concentration of the analyte in plasma at steady-state (Cavg)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time Frame: predose on days 1-4
|
predose on days 1-4
|
Linearity index (LI)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Accumulation ratio (RA) based on Cmax (RA,Cmax,N)
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
RA,AUC,N based on AUC0-τ
Time Frame: up to 104 hours after last drug administration
|
up to 104 hours after last drug administration
|
Number of subjects with clinically relevant findings in vital sign parameters (blood pressure (BP), pulse rate (PR))
Time Frame: up to 14 days after last drug administration
|
up to 14 days after last drug administration
|
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
Time Frame: up to 14 days after last drug administration
|
up to 14 days after last drug administration
|
Number of subjects with abnormal changes in laboratory parameters
Time Frame: up to 14 days after last drug administration
|
up to 14 days after last drug administration
|
Number of subjects with abnormal findings in physical examination
Time Frame: up to 14 days after last drug administration
|
up to 14 days after last drug administration
|
Occurrence of adverse events
Time Frame: up to 47 days
|
up to 47 days
|
Tolerability assessed by investigator on a 4-point scale
Time Frame: within 14 days after last drug administration
|
within 14 days after last drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
October 9, 2014
First Submitted That Met QC Criteria
October 9, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Estimate)
October 10, 2014
Last Update Submitted That Met QC Criteria
October 9, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- 202.833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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