Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: A randomized, single-dose, two-period, two-sequence crossover study

Srichaiya, Arunee; Longchoopol, Chaowanee; Oo-puthinan, Sarawut; Sayasathid, Jarun; Sripalakit, Pattana; Viyoch, Jarupa

doi:10.1016/j.clinthera.2008.10.018

Cited by 16 publications

(16 citation statements)

References 20 publications

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“…Pharmacokinetics parameters obtained in this research were similar to those found by Srichaiya et al [23] in a study with the same drug, at the same dose in a group of healthy Thai male volunteers, using an HPLC method with high sensitivity LOQ (0.05 μg/mL) as shown in Table 4.…”

Section: Discussionsupporting

confidence: 86%

“…It was concluded that the tested LAMOTRIGINE tablet (100 mg) elaborated by Humax Pharmaceutical S.A. is bioequivalent to the reference formulation, LAMICTAL ® 100 mg, manufactured by Glaxo operations UK Ltd. in terms of rate and amount of absorption, according to the guidances of Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) and FDA. Table 4: Comparison of lamotrigine pharmacokinetics obtained by Arunee Srichaiya et al [23] and those obtained in this study.…”

Section: Discussionmentioning

confidence: 68%

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Bioequivalence Evaluation of Two Formulations of Lamotrigine Tablets in Healthy Volunteers

Ruiz¹,

Cuesta²,

Parra³

2012

JBB

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Lamotrigine is a phenyltriazine used in the treatment of epilepsy and bipolar disorder type I. The purpose of this study was to compare the bioavailability in healthy Colombian volunteers of two brands of lamotrigine 100 mg tablets: a new generic formulation (test product) developed by Humax Pharmaceuticals S.A (Medellín, Col) and LAMICTAL ® (reference product) from Glaxo Operations UK Ltd (Ware, UK). A single-dose, randomized, two-period, two-sequence crossover study, with six weeks washout period, was performed. Blood samples were obtained from 0 to 144 hours after dosing and plasma lamotrigine levels were determined by a validated high performance liquid chromatographic (HPLC) method. The 90% confidence intervals (CIs) for the ratios of the ln AUC 0-∞ and ln C max means between the reference and test formulations were constructed under 80/125 rule for bioequivalence limit. Fourteen subjects were enrolled in the study, but only twelve completed both treatment periods. The estimated pharmacokinetic parameters of lamotrigine for the reference and test formulations were C max 2.314 ± 0.414 µg/mL, 2.226 ± 0.355 µg/mL; AUC 0-120 70.148 ± 10.824 µg.h/mL, 69.277 ± 13.432 µg.h/mL, and for AUC 0-∞ were 78.524 ± 16.000 µg.h/mL, 77.532 ± 15.255 µg.h/mL, respectively. The 90% CIs for the ln-transformed ratio (test/reference) of AUC 0-∞ and C max were 88.97 to 110.65 and 87.77 to 106.37, respectively. Conclusions: In this single dose study it was found that the test and reference products of lamotrigine 100 mg tablets complied with the regulatory criteria for equivalence with respect to rate and extent of absorption according to the guidances of Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) and FDA.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 68%

Bioequivalence Evaluation of Two Formulations of Lamotrigine Tablets in Healthy Volunteers

Ruiz¹,

Cuesta²,

Parra³

2012

JBB

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“…Indeed, the FDA recommends lamotrigine bioequivalence studies with 50-mg doses [ 33 ] . In this study, we provided evidence showing the feasibility of this approach, as previous studies employed 100 mg [ 30 ] . Given that lamotrigine pharmacokinetics are linear (i. e., dose-independent), the bioequivalence of 25-, 100-and 200-mg tablets can be extrapolated from our results [ 20 , 33 ] .…”

supporting

confidence: 49%

Bioequivalence of Lamotrigine 50-mg Tablets in Healthy Male Volunteers: a Randomized, Single-Dose, 2-Period, 2-Sequence Crossover Study

Pérez-Lloret

Olmos

Mena

et al. 2012

Arzneimittelforschung

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This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in this sample of fasting healthy volunteers. These results suggest that bioequivalence studies evaluating 50-mg doses of Lamotrigine are feasible and recommended, since such doses may minimize the risk of severe rash or Stevens-Johnson Syndrome. This study was registered at the Argentinean Clinical Trials National Registry (www.anmat.gov.ar), No 1666/2008.

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“…102 A similar result was found from the only Class II study from our literature search. 103 The best level of evidence in epilepsy patients supported the switch of LTG (sodium channel blocker) from brand to generic preparation. It remains controversial whether these findings can be extrapolated to other AEDs because LTG is by far one of the most widely used first-line AEDs.…”

Section: Part B: Generic Drugsmentioning

confidence: 99%

“…Six studies had LTG as the study AED. [100][101][102][103][104][105] Two studies had topiramate as the study focus 106,115 and the remaining studies adopted multiple drug regimens. [107][108][109][110][111] A good level of evidence came from a randomised controlled trial of 'generic-brittle' patients in a double-blind, multiple-dose, steady-state, fully replicated crossover bioequivalence study of LTG.…”

Section: Part B: Generic Drugsmentioning

confidence: 99%

An update of the Hong Kong Epilepsy Guideline: consensus statement on the use of antiepileptic drugs in Hong Kong

Jk¹,

Leung

et al. 2017

Hong Kong Med J

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Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: A randomized, single-dose, two-period, two-sequence crossover study

Cited by 16 publications

References 20 publications

Bioequivalence Evaluation of Two Formulations of Lamotrigine Tablets in Healthy Volunteers

Bioequivalence Evaluation of Two Formulations of Lamotrigine Tablets in Healthy Volunteers

Bioequivalence of Lamotrigine 50-mg Tablets in Healthy Male Volunteers: a Randomized, Single-Dose, 2-Period, 2-Sequence Crossover Study

An update of the Hong Kong Epilepsy Guideline: consensus statement on the use of antiepileptic drugs in Hong Kong

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