Not Yet RecruitingPhase 1ACTRN12610000883011

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

Bioequivalence assessment of generic darifenacin [Darisec(R - registered trademark) ] vs. innovator darifenacin [Enablex(R - registered trademak)] in healthy volunteers.

Sponsor

Center for Clinical Pharmacology Research Bdbeq S.A.

Enrollment

24 participants

Start Date

Nov 15, 2010

Study Type

Interventional

Conditions

Bioequivalence assessment between two formulations of darifenacin

Summary

The objective of the present trial is to assess the bioequivalence of a new formulation of extended release darifenacin -Darisec (R) 7.5 mg- vs. the innovator -Enablex(R) 7.5 mg- ; both given orally within 30 minutes of a high fat breakfast to healthy volunteers.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares how the body absorbs a generic version of darifenacin (a bladder control medication) versus the brand-name version. It is for healthy adults aged 18 to 50 with a normal body weight who are not taking other medications.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Simultaneous admininstration of Darifenacin, Darisec(R - registered trademark) 7.5 mg p.o. , single dose, cross over study design with one week wash out period in between.

Locations(1)

Montevideo, Uruguay

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ACTRN12610000883011