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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000894099

Acronym

None

Enrollment

Registered

2010-10-21

Start date

2010-12-06

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 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.

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 control treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy caucasian male or female subjects 18 to 50 years of age (inclusive) In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician. Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed. Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.

Exclusion criteria

Known hypersensitivity or severe adverse event to darifenacin or similar drugs. Urinary retention, narrow-angle glucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon. Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (>2 days in a week), severe constipation, gastrointestinal obstructive disorder, and gastric retention. Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats. Acute or chronic bronchospastic disease (including athma and Chronic Obstructive Pulmonary Disease). Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). Smokers of more than 5 cigarettes a week. Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration. Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study. Immunodeficiency diseases, including a positive HIV (Elisa or Western blot) test result. Positive hepatitis B Surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse within the 6 months prior to dosing. Use of prescription drugs within 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable. Participation in any clinical investigation within 4 weeks prior to dosing. Donation or loss of 400 ml or more of blood within 2 months prior to dosing. Significant illness within 2 weeks prior to dosing. Other protocol-defined inclusion/exclusion criteria may apply.

Outcome results