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Not Yet RecruitingPhase 1ACTRN12610000894099

Comparative evaluation of the absorption and disposition in the body of a generic formulation of darifenacin 15 mg against the innovator product in healthy fed volunteers.

Realtive Bioavailability and pharmacokinetic profiling of a generic darifenacin formulation [Darisec(R - registered trademark) extended release 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg] in healthy fed volunteers

Sponsor

Center for Clinical Pharmacology Research Bdbeq S.A.

Enrollment

24 participants

Start Date

Dec 6, 2010

Study Type

Interventional

Conditions

Bioequivalence assessment between two formulations of darifenacin 15 mg.

Summary

The objective of the present trial is to assess the bioequivalence and pharmacokinetic profile of a new extended release formulation of darifenacin [Darisec(R - registered trademark) 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 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 15 mg (a bladder medication) versus the original brand when taken with food. It is for healthy adults aged 18 to 50 with a normal body weight who do not have urinary, eye, or serious digestive conditions.

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 administration of Darifenacin, Darisec(R - registered trademark)15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the contro

Simultaneous administration of Darifenacin, Darisec(R - registered trademark)15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the control treatment.

Locations(1)

Montevideo, Uruguay

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ACTRN12610000894099