Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Tyrphostin AG-17 content 10 mg with 700 mg of L-Carnitine tartrate |
|
| Group 2 | Experimental | Tyrphostin AG-17 content 3.3 mg with 700 mg of L-Carnitine tartrate |
|
| Group 3 | Experimental | Tyrphostin AG-17 content 1 mg with 700 mg of L-Carnitine tartrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirfostina/L-Carnitina | Combination Product | Estudio clÃnico fase 1 para describir la seguridad biológica y la farmacocinética de la tirfostina AG-17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance assessment |
| 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmet, S.A de C.V. | Mexico City | Azcapotzalco | 02230 | Mexico |
The blood samples obtained as a result of this study will be used to describe a possible change and/or damage in the organism and for the quantification of tyrphostin AG-17, as well as all the data obtained by this research will be evaluated maintaining its confidentiality, adjusting its compliance with the Federal Law on Protection of Personal Data Held by Private Parties
Not provided
Not provided
Not provided
Not provided
Not provided
Assess 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.
Not provided
Not provided
Double (Participant, Investigator) The random assignment codes to the administration sequence will be under the protection of the Statistics Department. The Analytical Unit, the group of researchers from the Clinical Unit (medical staff) and the IS will remain blinded during the conduct of the study, the processing and analysis of the biological samples and in this way avoid biasing the results generated. Once the Clinical Phase is over, the opening code for the issuance of the Clinical Report and the Safety Report will be shared with the group of researchers of the Clinical Unit (medical staff).