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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00413426
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Study Completion: 2007-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety and tolerability

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇳 Mumbai, India