Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Topiramate coated tablet
Topiramate coated · 1 trial · 1 indication
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.
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.
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 when Cmax is obtained
Calculated by formula: T1/2\_Kel= Ln(2)/Kel.
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
| Arm | Type | Description |
|---|---|---|
| Test formulation | ACTIVE_COMPARATOR | Test 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 formulation | ACTIVE_COMPARATOR | Topamax® 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 |
| Name | Type | Description |
|---|---|---|
| Topiramate coated tablet | DRUG | Test formulation |
| Topamax® coated tablet | DRUG | Reference formulation |
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...
Topiramate coated is an oral tablet formulation studied for epilepsy, specifically tonic-clonic seizures. It is a coated tablet version of topiramate developed by GSK plc. The clinical program has focused on bioequivalence testing in healthy adult male volunteers rather than on new efficacy trials.
Topiramate coated acts as an antagonist at AMPA and kainate receptor subunits, including GRIA1, GRIA2, GRIA3, GRIA4, GRIK1, and GRIK5. By blocking these glutamate-gated ion channels, it reduces excitatory neurotransmission, which is the basis for its use in seizure disorders such as tonic-clonic epilepsy.
Topiramate coated is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical program for this coated tablet formulation of topiramate.
Topiramate coated is in Phase 1 development. It is an investigational formulation and is not described as approved. The single registered trial was a Phase 1 bioequivalence study, and no active trials are currently listed for this asset.
Topiramate coated has been studied in one completed trial, NCT01439438, titled Topiramate Bioequivalence Study Brazil - Fast. That Phase 1 study enrolled 26 healthy male volunteers aged 18 years and older in Brazil, used an active-controlled randomized design, and has completed.
Yes, topiramate coated and topiramate coated tablet refer to the same product. Topiramate coated tablet is simply the alternative name used for this GSK plc formulation, so searches under either name point to the same Phase 1 asset being studied in tonic-clonic epilepsy.