Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000894099
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
21/10/2010
Date last updated
21/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative evaluation of the absorption and disposition in the body of a generic formulation of darifenacin 15 mg against the innovator product in healthy fed volunteers.
Scientific title
Realtive Bioavailability and pharmacokinetic profiling of a generic darifenacin formulation [Darisec(R - registered trademark) extended release 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg] in healthy fed volunteers
Secondary ID [1] 252925 0
The trial does not have a secondary ID.
Universal Trial Number (UTN)
U1111-1117-5341
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence assessment between two formulations of darifenacin 15 mg. 258459 0
Condition category
Condition code
Other 258619 258619 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Simultaneous administration of Darifenacin, Darisec(R - registered trademark)15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the control treatment.
Intervention code [1] 257447 0
Treatment: Drugs
Comparator / control treatment
Simultaneous administration of Darifenacin, Enablex (R - registered trademark) 15.0 mg p.o., single dose, crossover study design with one week washout periodo in between before moving over to the intervention goup treatment.
Control group
Active

Outcomes
Primary outcome [1] 259465 0
Area Under the Curve (AUC) concentration of darifenacin/time (AUC0-t and AUC0-inf).
Darifenacin plasma concentration will be measured with Liquid Chromatography-Mass Spectromtry method and concentration vs. time curves will be plotted.
AUC0-t will be calculated using the trapezoidal rule.
AUC0-inf will be calculated extrapolating the last concentration point to infinity using the log-linear elimination rate constant method.
Timepoint [1] 259465 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
Primary outcome [2] 259466 0
Peak concentration (Cmax)
Darifenacin plasma concentration will be measured with Liquid Chromatography- Mass Spectrometry Method and concentration vs. time curves will be plotted.
Cmax will be taken directly from the darifenacin plasma concentration vs. time curve.
Timepoint [2] 259466 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
Secondary outcome [1] 266035 0
Time to Cmax (tmax).
Is the time elapsed from ingestion of darifenacin tablets to plasma peak concentration.
Timepoint [1] 266035 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
Secondary outcome [2] 266036 0
Absorption Rate Constant(Ka)
The absorption rate constant is the fractional rate of drug disappearance from the intestinal tract, measured in the log-linear phase of drug absorption.
Timepoint [2] 266036 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.
Secondary outcome [3] 266037 0
Elimination Rate Constant (Ke)
The elimiminaiton rate constant is the fractional rate of drug dissapearance from the peripheral compartment, measured in the log-linear phase of elimination.
Timepoint [3] 266037 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours.

Eligibility
Key inclusion criteria
Healthy caucasian male or female subjects 18 to 50 years of age (inclusive)
In good health, as determined by lack of clinically significant abnormalities at screening as judged by the physician.
Female subjects are required to use a medically accepted method of hormonal contraception or abstinence throughout the entire study period and for one week after the study is completed.
Body mass index within the range of 18.5 and 29.9 kg/m2 and weight at least 45 kg.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known hypersensitivity or severe adverse event to darifenacin or similar drugs.
Urinary retention, narrow-angle glucoma, 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 disorder, and gastric retention.
Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats.
Acute or chronic bronchospastic disease (including athma and Chronic Obstructive Pulmonary Disease).
Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
Smokers of more than 5 cigarettes a week.
Regular use of any drugs known to induce or inhibit hepatic drug metabolism (particularly those that affect CYP2D6) within 30 days prior to each study drug administration.
Any surgical or medical condition wich might significantly alter the absorption, distribution, metabolism or excretion of drugs which may jeopardize participation in the study.
Immunodeficiency diseases, including a positive HIV (Elisa or 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 1 month prior to dosing, or over-the-counter medication (vitamine, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol and ibuprofen are acceptable.
Participation in any clinical investigation within 4 weeks prior to dosing.
Donation or loss of 400 ml or more of blood within 2 months prior to dosing.
Significant illness within 2 weeks prior to dosing.
Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
University students and subjects from the general population will be invited to particpate in the study. After informed consent is signed, medical examination and labs screening ensues in order to prove the volunteer is healthy.
Once the volunteers passes clinical and laboratory check up, he is assigned to one tretment sequence.
Allocation will be concealed using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computarized sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Two-sequence, two period, balanced with administration of investigation products in fed conditions.
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2983 0
Uruguay
State/province [1] 2983 0
Montevideo

Funding & Sponsors
Funding source category [1] 257889 0
Commercial sector/Industry
Name [1] 257889 0
ELEA S.A.C.I.F. y A.
Country [1] 257889 0
Argentina
Primary sponsor type
Commercial sector/Industry
Name
Center for Clinical Pharmacology Research Bdbeq S.A.
Address
Br. Artigas 1632, cp 11600, Montevideo.
Country
Uruguay
Secondary sponsor category [1] 257088 0
None
Name [1] 257088 0
Address [1] 257088 0
Country [1] 257088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259917 0
Comite de Etica en la Investigacion. Universidad Catolica
Ethics committee address [1] 259917 0
8 de Octubre 2801. cp 11600, Montevideo.
Ethics committee country [1] 259917 0
Uruguay
Date submitted for ethics approval [1] 259917 0
Approval date [1] 259917 0
13/09/2010
Ethics approval number [1] 259917 0
A.04.09.10

Summary
Brief summary
The objective of the present trial is to assess the bioequivalence and pharmacokinetic profile of a new extended release formulation of darifenacin [Darisec(R - registered trademark) 15 mg] vs. the innovator [Enablex(R - registered trademark) 15 mg]; both given orally, within 30 minutes of a high fat breakfast, to healthy volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31809 0
Address 31809 0
Country 31809 0
Phone 31809 0
Fax 31809 0
Email 31809 0
Contact person for public queries
Name 15056 0
Francisco E. Estevez Carrizo, M.D.
Address 15056 0
Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano, Br. Artigas 1632. cp 11600 Montevideo.
Country 15056 0
Uruguay
Phone 15056 0
+59824876288
Fax 15056 0
Email 15056 0
francisco.estevez@bdbeq.com.uy
Contact person for scientific queries
Name 5984 0
Susana Parrillo, M.D.
Address 5984 0
Center for Clinical Pharmacology Research Bdbeq S.A.; Hospital Italiano, Br. Artigas 1632. cp 11600 Montevideo.
Country 5984 0
Uruguay
Phone 5984 0
+59824876288
Fax 5984 0
Email 5984 0
sparrillo@bdbeq.com.uy

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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