HealthyPhase 1NCT00413426
Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects
A Phase 1 study testing Darifenacin (DAR328) in people with Healthy, run by Novartis at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Darifenacin (DAR328)
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Darifenacin (DAR328)
- Keywords
- Pharmacokinetics, oral, single dose, table, suspension, release, darifenacin, healthy subjects, Healthy volunteers study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darifenacin (DAR328)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJun 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413426
- Sponsor's protocol ID
- CDAR328B2101
- Status last verified
- Apr 2016
- First submitted
- 18 Dec 2006
- Last updated
- 12 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00413426
- Acronym / sponsor ID
- CDAR328B2101
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, oral, single dose, table, suspension, release, darifenacin, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Jun 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darifenacin (DAR328) | Drug | – |
Primary outcome
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
1 secondary outcome
Safety and tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darifenacin (DAR328) in people with Healthy, run by Novartis at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.