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

NCT00413426 | Completed Phase 1

• 1 other identifier: CDAR328B2101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics; oral; single dose; table; suspension; release; darifenacin; healthy subjects; Healthy volunteers study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety and tolerability

Interventions

Darifenacin (DAR328) DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead
• Procter and Gamble: collaborator

Study Sites (1)

Novartis Investigative Site

Mumbai, India

Location

MeSH Terms

Interventions

darifenacin

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: June 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

IN (1)