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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00413426
First received: December 18, 2006
Last updated: November 29, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Darifenacin (DAR328)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • Safety and tolerability

Estimated Enrollment: 28
Study Start Date: June 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413426

Locations
India
Novartis Investigative Site
Mumbai, India
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00413426     History of Changes
Other Study ID Numbers: CDAR328B2101
Study First Received: December 18, 2006
Last Updated: November 29, 2007
Health Authority: India: Ministry of Health

Keywords provided by Novartis:
Pharmacokinetics
oral
single dose
table
suspension
 release
darifenacin
healthy subjects
Healthy volunteers study

Additional relevant MeSH terms:
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013