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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

Inclusion Criteria5

  • 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 Criteria10

  • 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.

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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.

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