Comparative assessment of the absorption of a generic formulatons of darifenacin against the innovator darifenacin product in healthy volunteers.

Phase 1

• Conditions: Bioequivalence assessment between two formulations of darifenacin; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12610000883011
• Lead Sponsor: Center for Clinical Pharmacology Research Bdbeq S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Caucasians
BMI>18.5 and <29.9 kg/m2
Healthy based in medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Able to comply wiht study procedures.
Able to give informed written consent for participation in the study.

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaciton to darifenacin or any related drug.
Resting heart rate > 70 bpm.
Pregnant or breast-feeding.
Ingestion of medicines at any time within 14 days before the inception of the trial.
A recent history of alcoholism (<2 years) or of moderate alcohol use (180 ml/day), or consumption of alcohol within 48 hours prior to the start of the study.
Smoker, more than 10 ciegarrettes per day.
Presence of clinically significant abnormal laboratory values during screening.
History of drug addiction or testing positive in pre-study drug scan.
Donation of blood (350 ml) within 90 days prior to receiving the study drug.
History of psychiatric disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified