Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers.
Recruitment status was Not yet recruiting
The proposed study was designed as a randomized two-sequence, two period crossover trial to assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R)7.5 mg]in healthy volunteers in postprandial state.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||Comparative Bioavailability of Darifenacin Extended Release Oral Formulation [Darisec(R)7.5 mg vs. Enablex(R)7.5 mg]: Single-dose, Postprandial State, Randomized, Two-sequence, Two-period, Crossover Study in Healthy Volunteers.|
- Extent of absorption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Extent of absorption will be measured using the area under the plasma concentration of darifenacin vs time from time 0 to the last sample point (AUC0-t) and from time 0 to infinity (AUC0-inf.
- Rate of absorption [ Time Frame: 72 ] [ Designated as safety issue: No ]Rate of abosorption will be measured using peak concentration of darifenacin (Cmax)taken from the concentration vs. time curve.
- Time to peak concentration (tmax) [ Time Frame: 72 ] [ Designated as safety issue: No ]Tmax is the time elapsed from ingestion of darifenacin tablets to plasma peak concentration (Cmax)
- Elimination rate constant (Ke) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]The elimination rate constant is the fractional rate of drug disappearance form the peripheral compartement, measured in the log-linear elimination phase.
- Elimination Half-life (t1/2e) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]t1/2e is the time in which the concentration in the log-linear elimination phase drops by half.
- Systemic clearance (Cls) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]Cls is the amount of plasma volume units that are totally cleared of the drug in the unit of time.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: Darisec(R) 7.5 mg||
Single dose 7.5 mg tablets of darifenacin
|Active Comparator: Enablex(R) 7.5 mg||
Single dose 7.5 mg tablets of Darifenacin
Darifenacin is a muscarinic receptor antagonist drug used to treat overactive bladder. There is a new formulation of darifenacin extended release developed by an argentinian pharmaceutical company. A bioequivalence study will be performed to validate pharmaceutical development before introducing the product in the market.
The purpose in this study is to evaluate the relative bioavailability, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7.5 mg] vs. the innovator [Enablex(R) 7.5 mg]in 24 healthy uruguayan volunteers after a high fat breakfast of 1000 calories (50% fat, 35% carbohydrates, and 15% proteins)to establish their average bioequivalence.
The bioequivalence will be evaluated using:
- The Area Under the Curve (AUC),
- The peak plasma concentration (Cmax).
The pharmacokinetic characteristics of the drug formulations will be described calculating:
- The time to peak concentration (Tmax)
- The elimination constant (Ke)
- The elimination half-life (t1/2e)
- The systemic clearance (Cls)
Safety will be evaluated recording:
- Reported adverse events
- Vital signs (blood pressure, heart rate, body temperature)
- Laboratory analysis (hemogram, hepatic enzymes, creatinine, sugar in blood, etc.)
- EKG and chest XRays
Bioequivalence will be claimed if the drugs comply with local and FDA regulatory requirements:
- Mean AUCt/AUCr and 90% confidence interval within 0.80-1.25
- Mean Cmaxt/Cmaxr and 90% confidence interval within 0.80-1.25
Pharmacokinetic profiling will be evaluated by describing the pharmacokinetic characteristics of both drug in adequate two-way tables.
Safety will be evaluated comparing incidence of adverse events/adverse effects for both products.
|Contact: Federico Santoro, MDemail@example.com|
|Contact: Joanna Steimberg, MBAfirstname.lastname@example.org|
|Center for Clinical Pharmacology Research (CCPR) Bdbeq S.A. Hospital Italiano.||Not yet recruiting|
|Montevideo, Uruguay, 11600|
|Contact: Francisco E. Estevez-Carrizo, M.D. +59824876288 email@example.com|
|Contact: Mónica Cedrés, Pharm. B. +59824876288 firstname.lastname@example.org|
|Principal Investigator: Susana Parrillo, M.D.|
|Study Director:||Francisco E. Estevez-Carrizo, MD||Univerisity of Montevideo. Biomedical Science Center.Prudencio de Pena 2440, 11600 Montevideo. Uruguay|
|Principal Investigator:||Susana Parrillo, M.D.||Center for Clinical Pharmacology Research Bdbeq S.A., Br. Artigas 1632. c.p. 11600 Montevideo. Uruguay.|