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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014