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Topamax coated

Phase 1

Epilepsy, Tonic-Clonic | Small molecule | Neurology |GSK plc|Last Updated: Jun 28, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01439438Topiramate Bioequivalence Study Brazil - FastPHASE1 COMPLETED 26Jul 22, 2011Sep 11, 2011Jun 28, 20171 Brazil
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Study Endpoints
Primary Endpoints
Area under curve of plasma concentration of drug from time 0 (zero) from time t (last measurable concentration)
Collection points from time 0 to 192 hours evaluated in two periods

The area under the plot of plasma concentration of drug against time (non-compartimental method), after drug administration, defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration), by linear trapezoidal rule. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.

Maximum observed concentration of drug through time (Cmax)
Collection points from time 0 to 192 hours evaluated in two periods

Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement obtained directly of the plasma concentration curve of the drug (non-compartimental method). Occurring at Tmax.

Area under curve of plasma concentration of drug from the time 0 (zero) extrapolated to infinity (AUC0-inf)
Collection points from time 0 to 192 hours evaluated in two periods

Measurement obtained directly from the plasma concentration curve of drug against time (non-compartimental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by formula AUC0-inf=AUClast +Clast/Kel, where Clast is the Last measurable concentration and Kel is the first order rate constant associated with the terminal portion of the curve.

Time of maximum observed concentration (Tmax)
Collection points from time 0 to 192 hours evaluated in two periods

Time when Cmax is obtained

Terminal half-life - T1/2
Collection points from time 0 to 192 hours evaluated in two periods

Calculated by formula: T1/2\_Kel= Ln(2)/Kel.

First order rate constant associated with the terminal portion of the curve (Kel)
Collection points from time 0 to 192 hours evaluated in two periods

This parameter is estimated by the angular coefficient of the regression line, calculated by the minimum squares method, of the natural logarithm of the concentration versus time for the last four concentrations values (or at least three) above the quantification limit

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Test formulationACTIVE_COMPARATORTest product: Topiramate 100 mg coated tablets produced by Dr. Reddy's Laboratories Ltd. in Period 1, followed by 28 days washout period during which no medication was administered; followed by reference product: Topamax® 100 mg coated tablets in Period 2
Reference formulationACTIVE_COMPARATORTopamax® 100 mg coated tablets marketed by Janssen-Cilag farmacêutica Ltda. in Period 1, followed by 28 days washout period during which no medication was administered; followed by test product: Topiramate 100 mg coated tablets produced by Dr. Reddy's Laboratories Ltd. in Period 2
Interventions
NameTypeDescription
Topiramate coated tabletDRUGTest formulation
Topamax® coated tabletDRUGReference formulation
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male * Age between 18 and 50 years * Body mass index between 19 and 28,5 kg/m2 * Good health conditions * Capable to understand the study's nature and aim, including risks and adverse effects and with intention to cooperate with the researcher and to act in compliance with req...

Countries:Brazil
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