Phase 1
Completed N=56
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Healthy
Source: ClinicalTrials.gov NCT02516098 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) — 91; 80 picogram (pg)/millilitre (mL)
Summary
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
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 | — |
Eligibility Criteria
Inclusion criteria
healthy males and females, aged 18-50years, BMI 18,5-30
Exclusion criteria
History of hypersensitivity or allergy to IMP
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. Informational only — not medical advice.