Phase 1
Completed N=30
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Healthy
Source: ClinicalTrials.gov NCT01734902 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax) — 70.3; 77.1 Picogram/millilitre [pg/mL]
Summary
The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax) |
70.3; 77.1 | — |
| PRIMARY Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
564.0; 608.0 | — |
| SECONDARY Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ ) |
623.0; 668.0 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01734902). 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.