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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000883011

Enrollment

Registered

2010-10-19

Start date

2010-11-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Outcome results