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Clinical Trial Summary

Evaluate the biological safety and pharmacokinetics of tyrphostin AG-17 present in the solid oral formulations of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17 contained 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality.


Clinical Trial Description

Describe the tolerance of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17, containing 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in research subjects. healthy Mexican nationals, describing: type, frequency, duration, consequence, relationship with clinical history, management, follow-up; criteria: seriousness, severity; and classification of the AE or ADRs in accordance with the current NOM-220-SSA1 and estimate if there are differences by gender. Assess the effects on body functions of the fixed dose combination, in three different concentrations of the compound tyrphostin AG-17 content 10 mg, 3.3 mg and 1 mg respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality through the measurement of physiological markers and estimate if there are differences by gender. Obtain the biological blood samples necessary for the quantification of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg in accordance with Good Clinical Practices, always taking care to protect the vulnerability and integrity of the research subjects. Quantifying the compound tyrphostin AG-17 with a previously validated bioanalytical method. Estimate the pharmacokinetic parameters of the compound tyrphostin AG-17 at concentrations of 10 mg, 3.3 mg and 1 mg. Describe the pharmacokinetic parameters of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg in terms of Cmax, AUC0-t, AUC0-inf and as secondary parameters AUCExt, TMR, Tmax, Ke, t½, Vd and CL and estimate if there are differences by gender. Establish the possible linearity of the compound tyrphostin AG-17 in concentrations of 10 mg, 3.3 mg and 1 mg. Correlate the pharmacokinetic markers with the presence of AE or ADRs, with the hemodynamic markers and with the physiological markers and present a dynamic profile of the compound under investigation to propose a pharmacological response that is of potential further interest. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05487781
Study type Interventional
Source Molecule X LLC
Contact
Status Enrolling by invitation
Phase Early Phase 1
Start date May 24, 2022
Completion date July 29, 2022

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