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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413426

Enrollment

Registered

2006-12-19

Start date

2006-06-30

Completion date

2007-09-30

Last updated

2016-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

DRUGDarifenacin (DAR328)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	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

Measure	Time frame
Safety and tolerability	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026