Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects

Study Overview
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Brief Summary
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This purpose of this study is to compare the how the body changes the blood level of a single dose of darifenacin when given as 7.5 mg modified release tablet and the modified release liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.

Official Title
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An Open-labeled, Randomized, Single Dose, Three Period, 2-sequence Crossover Study to Investigate the Pharmacokinetics of Darifenacin When Given as 7.5 mg Oral Doses of a Modified Release Suspension, as Compared to the Commercial Modified Release Tablet in Healthy Adult

Conditions
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Healthy

Intervention / Treatment
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* Drug: Darifenacin (DAR328)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, male or female subjects age 18 to 50 years of age (inclusive) In good health Female subjects either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years) Body mass index within the range of 18.5 to 29.9 kg/m2 and weigh at least 45 kg Exclusion Criteria: Smokers History of Urinary retention, narrow-angle glaucoma, 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 disorders, and gastric retention. Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and 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 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable. Participation in any clinical investigation within 4 weeks prior to dosing Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing. Significant illness within 2 weeks prior to dosing. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darifenacin (DAR328)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the PK of a single dose of 7.5 reference modified release tablet of darifenacin and the tested modified release liquid suspension (1.5 mg/ml) of darifenacin under fasted conditions in healthy subjects |  |  | 
| Comparison of the PK of a single dose of darifenacin when given as an oral dose of a 7.5 mg modified release liquid suspension in the fed and fasted states |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, oral, single dose, table, suspension, release, darifenacin, healthy subjects, Healthy volunteers study