Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: A single-dose, randomized, open-label, crossover study

Girolamo, Guillermo Di; Keller, Guillermo Alberto; Santos, Antonio Raúl de los; Schere, Daniel; Gonzalez, Claudio

doi:10.1016/j.clinthera.2008.11.005

Cited by 18 publications

(16 citation statements)

References 22 publications

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Section: Discussionsupporting

confidence: 83%

“…4 These findings are consistent with previous studies of T4 pharmacokinetics studied in healthy volunteers and other patient populations. [4][5][6] Therefore, the oral form of thyroxine is a suitable route of administration in this patient population. The hemodynamic responses following T4 administration were also similar between groups; however, since a control group (no thyroxine administration) was not used in this study, we cannot exclude the possibility that hemodynamics improved simply with time from the sympathetic storm usually seen at time of brain death and that the administration of thyroxine has no effect.…”

Section: Discussionsupporting

confidence: 83%

“…If the 95% CI fell between 85 and 125%, the two drug administrations were considered bioequivalent. 4 The number of inotropes/vasopressors was compared between groups at baseline and at time of procurement and expressed as median (Q1, Q3). A Wilcoxan two-sample test was used for between-group comparisons of the number of organs donated.…”

Section: Discussionmentioning

confidence: 99%

“…The target sample size for the study was 34 patients, which was based on the sizes of previous studies of thyroxine pharamcokinetics. [4][5][6] No formal sample size calculation was performed. The study drug was administered once consent for organ donation was received, and this point in time was designated as time zero.…”

Section: With Approval From the University Of Western Ontario Researcmentioning

confidence: 99%

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Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study

Sharpe

Rassel

Haddara

2013

Can J Anesth/J Can Anesth

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Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study La voie orale permet d'obtenir des taux sériques de thyroxine (T4) comparables à la voie intraveineuse dans le cadre d'un protocole de réanimation hormonale chez les donneurs d'organes: une étude randomisée à double insu Abstract Background Thyroxine (T4) administration is advocated in the management of organ donors; however, the bioavailability of oral thyroxine is unknown in this patient population. Objective The primary objective of this study was to compare the percentage of the study time (from study drug administration to organ procurement) that patients in the oral vs the intravenous group required inotropic support. Secondary objectives included plasma levels of T3 and T4 and number of organs donated following oral vs intravenous T4 administration. Design Randomized double-blinded study. Setting Adult medical-surgical intensive care unit. Patients Thirty-two adult solid organ donors. Interventions Patients were randomized to receive either an oral or intravenous dose of T4 (2 lgÁkg -1 ). All patients received an oral and intravenous study drug preparation, one of which was a placebo. The study was double-blinded, and randomization occurred in blocks of four and six. Measurements The number and duration of inotropic/ vasopressor therapies and free serum levels of T3 and T4 were determined hourly until procurement. Main results Following T4 administration, all patients remained on inotropic/vasopressor therapy for the same mean (SD) duration [93 (3)%] of the study period. There was a similar and gradual decrease in the number and dosages of inotropes/vasopressors required in both groups. There was no difference in T3 or T4 levels between groups. Oral bioavailability of T4 was 93% of the intravenous group at six hours and 91% overall. At six hours, the mean area under the curve for T4 was similar between the intravenous group [92.2 (33)

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Section: Discussionsupporting

confidence: 83%

Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Section: With Approval From the University Of Western Ontario Researcmentioning

confidence: 99%

See 2 more Smart Citations

Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study

Sharpe

Rassel

Haddara

2013

Can J Anesth/J Can Anesth

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“…LVX tablets are available in the market for the treatment of hypothyroidism for pediatrics. [7]. One of the greatest challenges in pediatric pharmacology has been optimization of oral drug delivery.…”

Section: Introductionmentioning

confidence: 99%

Development of Oral Fast-Disintegrating Levothyroxine Films for Management of Hypothyroidism in Pediatrics

Zhang¹,

Han²,

Wang³

et al. 2015

Trop. J. Pharm Res

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A case study on the in silico absorption simulations of levothyroxine sodium immediate‐release tablets

Kocic¹,

Homšek²,

Dačević³

et al. 2012

Biopharm & Drug Disp

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The aim of this case study was to develop a drug-specific absorption model for levothyroxine (LT4) using mechanistic gastrointestinal simulation technology (GIST) implemented in the GastroPlus™ software package. The required input parameters were determined experimentally, in silico predicted and/or taken from the literature. The simulated plasma profile was similar and in a good agreement with the data observed in the in vivo bioequivalence study, indicating that the GIST model gave an accurate prediction of LT4 oral absorption. Additionally, plasma concentration-time profiles were simulated based on a set of experimental and virtual in vitro dissolution data in order to estimate the influence of different in vitro drug dissolution kinetics on the simulated plasma profiles and to identify biorelevant dissolution specification for LT4 immediate-release (IR) tablets. A set of experimental and virtual in vitro data was also used for correlation purposes. In vitro-in vivo correlation model based on the convolution approach was applied in order to assess the relationship between the in vitro and in vivo data. The obtained results suggest that dissolution specification of more than 85% LT4 dissolved in 60 min might be considered as biorelevant dissolution specification criteria for LT4 IR tablets.

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Bioequivalence of two levothyroxine tablet formulations without and with mathematical adjustment for basal thyroxine levels in healthy Argentinian volunteers: A single-dose, randomized, open-label, crossover study

Cited by 18 publications

References 22 publications

Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study

Oral and intravenous thyroxine (T4) achieve comparable serum levels for hormonal resuscitation protocol in organ donors: a randomized double-blinded study

Development of Oral Fast-Disintegrating Levothyroxine Films for Management of Hypothyroidism in Pediatrics

A case study on the in silico absorption simulations of levothyroxine sodium immediate‐release tablets

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