CClinicalTrials.gg
Sign In
CompletedNCT02261077Updated Oct 10, 2014

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

A Phase 1 interventional study of Hyoscine butylbromide and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-10.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Buscopan, single rising doses

    Drug: Hyoscine butylbromide

  • Experimental
    Buscopan, multiple rising doses

    Drug: Hyoscine butylbromide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHyoscine butylbromide

    Also known as: Buscopan®

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Maximum measured concentration of analyte in plasma (Cmax)

    Time frame: up to 104 hours after last drug administration

  2. 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

  3. 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

Secondary outcomes

  1. Time from dosing to maximum measured concentration (tmax)

    Time frame: up to 104 hours after last drug administration

  2. 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

  3. Terminal rate constant in plasma (λz)

    Time frame: up to 104 hours after last drug administration

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

    Time frame: up to 104 hours after last drug administration

  5. Mean residence time of the analyte in the body (MRTpo)

    Time frame: up to 104 hours after last drug administration

  6. Total/apparent clearance in plasma after extravascular administration (CL/F)

    Time frame: up to 104 hours after last drug administration

  7. 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

  8. 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

  9. 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

  10. 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

  11. Average concentration of the analyte in plasma at steady-state (Cavg)

    Time frame: up to 104 hours after last drug administration

  12. 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

  13. 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

  14. Linearity index (LI)

    Time frame: up to 104 hours after last drug administration

  15. Accumulation ratio (RA) based on Cmax (RA,Cmax,N)

    Time frame: up to 104 hours after last drug administration

  16. RA,AUC,N based on AUC0-τ

    Time frame: up to 104 hours after last drug administration

  17. 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

  18. Number of subjects with clinically relevant findings in 12-lead electrocardiogram

    Time frame: up to 14 days after last drug administration

  19. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to 14 days after last drug administration

  20. Number of subjects with abnormal findings in physical examination

    Time frame: up to 14 days after last drug administration

  21. Occurrence of adverse events

    Time frame: up to 47 days

  22. Tolerability assessed by investigator on a 4-point scale

    Time frame: within 14 days after last drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02261077
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
May 2007
Primary completion
Jul 2007
Last update
Oct 10, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion