Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000883011
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
19/10/2010
Date last updated
20/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulatons of darifenacin against the innovator darifenacin product in healthy volunteers.
Scientific title
Bioequivalence assessment of generic darifenacin [Darisec(R - registered trademark) ] vs. innovator darifenacin [Enablex(R - registered trademak)] in healthy volunteers.
Secondary ID [1] 252912 0
None
Universal Trial Number (UTN)
U1111-1117-4887
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bioequivalence assessment between two formulations of darifenacin 258395 0
Condition category
Condition code
Other 258573 258573 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 admininstration of Darifenacin, Darisec(R - registered trademark) 7.5 mg p.o. , single dose, cross over study design with one week wash out period in between.
Intervention code [1] 257394 0
Treatment: Drugs
Intervention code [2] 257442 0
Treatment: Drugs
Comparator / control treatment
Simultaneous administration of Darifenacin, Enablex(R - registered trademark) 7.5 mg p.o. single dose cross over study design with one week wash out period in between.
Control group
Active

Outcomes
Primary outcome [1] 259408 0
Area Under the Curve concentration of Darifenacin/time (AUC0-t and AUC0-inf).
Darifenacin plasma concentration will be measured with a Liquid Chromatography-Mass Spectrometry method and concentration vs. time curves will be plotted
Area Under the Curve (AUC0-t) will be calculated using the trapezoidal rule.
AUC0-inf will be calculated extrapolating the last cocentration point to infinity using the log-linear elimination rate constant method.
Timepoint [1] 259408 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours.
Secondary outcome [1] 265949 0
Maximum concentration (Cmax).
Darifenacinn plasma concentration will be measured with a Liquid Chromatography-Mass Spectrometry method and concentration vs. time curves will be plotted
Peak concentration (Cmax) will be directly taken from the darifenacin plasma concentration vs. time curve.
Timepoint [1] 265949 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours.
Secondary outcome [2] 266019 0
Time to peak concentrarion (Cmax) .
It is measured on the abscissa from time 0 to the Cmax time.
Timepoint [2] 266019 0
0, 0:30, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours.

Eligibility
Key inclusion criteria
Caucasians
BMI>18.5 and <29.9 kg/m2
Healthy based in medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Able to comply wiht study procedures.
Able to give informed written consent for participation in the study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known hypersensitivity or idiosyncratic reaciton to darifenacin or any related drug.
Resting heart rate > 70 bpm.
Pregnant or breast-feeding.
Ingestion of medicines at any time within 14 days before the inception of the trial.
A recent history of alcoholism (<2 years) or of moderate alcohol use (180 ml/day), or consumption of alcohol within 48 hours prior to the start of the study.
Smoker, more than 10 ciegarrettes per day.
Presence of clinically significant abnormal laboratory values during screening.
History of drug addiction or testing positive in pre-study drug scan.
Donation of blood (350 ml) within 90 days prior to receiving the study drug.
History of psychiatric disorder.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computarised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2010
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] 2971 0
Uruguay
State/province [1] 2971 0
Montevideo

Funding & Sponsors
Funding source category [1] 257882 0
Commercial sector/Industry
Name [1] 257882 0
ELEA S.A.C.I.F. y A.
Country [1] 257882 0
Argentina
Primary sponsor type
Commercial sector/Industry
Name
Center for Clinical Pharmacology Research Bdbeq S.A.
Address
Br. Artigas1632. cp 11600, Montevideo
Country
Uruguay
Secondary sponsor category [1] 257083 0
None
Name [1] 257083 0
Address [1] 257083 0
Country [1] 257083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259908 0
Comite de Etica en la Investigaci?n. Universidad Catolica.
Ethics committee address [1] 259908 0
8 de Octubre 2738. 11600 Montevideo
Ethics committee country [1] 259908 0
Uruguay
Date submitted for ethics approval [1] 259908 0
Approval date [1] 259908 0
13/09/2010
Ethics approval number [1] 259908 0
A.05.09.10

Summary
Brief summary
The objective of the present trial is to assess the bioequivalence of a new formulation of extended release darifenacin -Darisec (R) 7.5 mg- vs. the innovator -Enablex(R) 7.5 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 31770 0
Address 31770 0
Country 31770 0
Phone 31770 0
Fax 31770 0
Email 31770 0
Contact person for public queries
Name 15017 0
Susana Parrillo
Address 15017 0
Hospital Italiano.
Br. Artigas1632.
cp 11600 Montevideo.
Country 15017 0
Uruguay
Phone 15017 0
+59824876288
Fax 15017 0
Email 15017 0
sparrillo@bdbeq.com.uy
Contact person for scientific queries
Name 5945 0
Francisco E. Estevez-Carrizo
Address 5945 0
Hospital Italiano.
Br. Artigas 1632.
cp 11600. Montevideo
Country 5945 0
Uruguay
Phone 5945 0
+59824876288
Fax 5945 0
Email 5945 0
francisco.estevez@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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.