drugset / Trial / NCT01734902
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
The objective of the current trial is to establish the bioequivalence of 2 hyoscine butylbromide dose forms following oral administration.
Timeline
- Start
- 2012-11-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
Outcome
Missed primary endpoint
registry Adjusted gMean ratio T/R (%) 86.97 (90% CI 74.046 to 102.151) NCT01734902 ↗
registry Adjusted gMean ratio T/R (%) 89.05 (90% CI 77.26 to 102.62) NCT01734902 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyoscine butylbromide | Unknown | — | Oral |
Indications
No indication recorded.