Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir
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|ClinicalTrials.gov Identifier: NCT03631316|
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Cytomegalovirus Infections Pharmacokinetics Therapeutic Equivalency||Drug: Generic Valganciclovir Drug: Innovative Valganciclovir||Not Applicable|
Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In the absence of prophylaxis, the frequency of CMV disease in high-risk recipients (R- / D +) is 60% and 20% for intermediate-risk patients (R + / D + or -). For universal prophylaxis, the antivirals most commonly used are valganciclovir (valGCV) and IV ganciclovir. ValGCV, a prodrug of ganciclovir, has a bioavailability of 60%, which represents more than 10 times that those obtained with ganciclovir.
Pharmacokinetic studies of Valganciclovir in SOTR have been demonstrated that insufficient doses can diminish its clinical efficacy and the development of viral resistance, while excessive doses can increase its toxicity.
The risk of viremia may be associated with ineffective plasma doses, as described by Wiltshire et al., where values of the area under the curve (AUC) between 40 and 50 μg/h/ml were associated with a lower incidence of viremia, while lower AUC values are associated with an increase 8 times more for viral replication rates. As a result, pharmacokinetic studies in SOTR guide the investigators in continuing with the research of their clinical impact.
A generic drug before their release to the market needs to show that is bioequivalent with the innovative drug, assuming that it has the same therapeutic effects.
The studies for demonstrate bioequivalence are carried out in controlled conditions with healthy participants, different of SOTR characteristics as: age, gender, race, comorbidities and concomitant medication. In addition, the excipients used in generic drug are different from those of the innovative drug, so the properties of the formulation can be modified (particle size or half-life), therefore, the efficacy and drug safety.
The primary outcome will be compare the pharmacokinetic parameters of the innovative versus generic formulation of valGCV in renal transplant recipients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Pharmacovigilance study, prospective, observational, analytical, single center, cross over design, with random assignment to the sequence of both formulations in the same patient. Our aim will be compare the pharmacokinetic parameters of the innovative versus generic formulation of valGCV in renal transplant recipients under valGCV prophylaxis in the early posttransplant stage.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Each participant will take both formulations. Groups will be formed regarding the order in which the different formulations of valganciclovir will be analyzed. Both formulations will be given in two identical container numbered in the specific order assigned. The order of administration of the drug will be randomized, neither the researcher nor the patient will know the order of the randomization.|
|Official Title:||Comparison on Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir in Kidney Transplant Recipients|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||October 30, 2018|
|Actual Study Completion Date :||November 1, 2018|
Experimental: Generic valganciclovir
Participants will receive generic formulation (Pisa) of valganciclovir, 450 mg tablets, total dosage 900 mg daily for 4 days.
Drug: Generic Valganciclovir
900 mg daily during 4 days
Other Name: Valganciclovir Pisa
Active Comparator: Innovative valganciclovir
The same participant will receive innovative drug valcyte (roche), 450 mg tablets, total dosage 900 mg daily during 4 days.
Drug: Innovative Valganciclovir
900 mg daily during 4 days
Other Name: Valcyte
- Area Under the Curve, AUC (ng/h/mL) [ Time Frame: At day 4 of treatment ]AUC (ngh/mL) in both drugs (innovative and generic)
- Maximum serum concentration, Cmax (ng/mL) [ Time Frame: At day 4 of treatment ]Cmax (ng/mL) in both drugs (innovative and generic)
- Initial concentration, C0 (ng/mL) [ Time Frame: At day 4 of treatment ]C0 (ng/mL) in both drugs (innovative and generic)
- Total clearance of the drug, CL/F (L/h) [ Time Frame: At day 4 of treatment ]CL/F (L/h), in both drugs (innovative and generic)
- Distribution volume, Vd/F (L/h) [ Time Frame: At day 4 of treatment ]Vd/F (L/h), in both drugs (innovative and generic)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631316
|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|
|Mexico City, Mexico, 14080|
|Principal Investigator:||Luis E Morales-Buenrostro, PhD||INCMNSZ|