Phase 1 N=56 Randomized Double-blind Treatment

Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02516098 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) — 91; 80 picogram (pg)/millilitre (mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: hyoscine butylbromide (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)	91; 80	—
PRIMARY AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)	807; 725	—
SECONDARY Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).	847; 760	—
SECONDARY Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)	187; 170	—

Summary

Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.

Eligibility Criteria

Inclusion criteria

healthy males and females, aged 18-50years, BMI 18,5-30

Exclusion criteria

History of hypersensitivity or allergy to IMP

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02516098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.