Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Topamax 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...
Topamax coated is a small molecule being developed for epilepsy, specifically tonic-clonic seizures. It is currently in Phase 1 clinical development as an investigational drug, meaning it has not yet been approved for use. The drug is being studied in a clinical trial in Brazil.
Topamax coated is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this investigational small molecule for the treatment of epilepsy, specifically tonic-clonic seizures.
Topamax coated is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for epilepsy.
Topamax coated has one completed clinical trial, NCT01439438, titled "Topiramate Bioequivalence Study Brazil - Fast." This Phase 1 study enrolled 26 healthy male volunteers aged 18 years and older in Brazil. The trial was active-controlled and randomized, though it was not double-blinded.
Topamax coated is a formulation of topiramate, as indicated by the clinical trial title referencing topiramate bioequivalence. The study NCT01439438 was designed to assess the bioequivalence of this coated formulation compared to a reference product in healthy volunteers.