Trial reportBritish journal of clinical pharmacology2019
Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).
Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06115538 (Comparison of Blood Dopamine Levels in Idiopathic Parkinson's Patients Receiving Levodopa Carbidopa Entacapone or Levodopa Benserazide), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparison of Blood Dopamine Levels in Idiopathic Parkinson's Patients Receiving Levodopa Carbidopa Entacapone or Levodopa Benserazide
Who cites it
3 citing papers in PubMed.
- Pharmacokinetics and Bioequivalence Study of Levodopa and Benserazide Tablets in Healthy Chinese Subjects Under Fasting and High-Fat Meal Conditions.Clinical pharmacology in drug development · 2026Trial
- Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator (Madopar).British journal of clinical pharmacology · 2019Trial
- Inhaled Levodopa for the Management of OFF Episodes in Parkinson's Disease: A Cost-Effectiveness Analysis.PharmacoEconomics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsWhile several generic preparations of levodopa/carbidopa and levodopa/benserazide (LBD) are currently available, pharmacokinetic (PK) equivalence and therapeutic equivalence studies with levodopa generics are not available in Italy. Lack of data on generic formulations is a critical factor for their limited use in this country and often lead patients to refuse the generic version of the branded drug.
methodsAn experimental, 2-centre, randomized, double-blind, 2-sequence, noninferiority cross-over study was designed to evaluate both the PK equivalence and clinical equivalence of multiple doses of the generic preparation of LDB, Teva Italia, compared to the originator (Madopar). Forty-three out-patients with a diagnosis of idiopathic Parkinson's disease on LDB, were recruited and randomly assigned to 1 of 2 study sequences: generic-originator or originator-generic. Clinical evaluations were performed at the end of each study period. A PK study with an LDB fixed dose (100 + 25 mg) was performed in a subpopulation of 14 subjects.
resultsClinical data showed a reduction of 0.49 and 1.54 in the mean UPDRS III scores for the LDB and the originator, respectively. The 95% CIs [-2.21: 0.11] of the mean difference original vs LDB are smaller than the clinically significant difference of 3 UPDRS III points, supporting the conclusion that the treatment with LDB is not inferior to the originator. No statistically significant differences were found with respect to area under the curve to last dose, half-life, maximum concentration, time to maximum concentration and last observed concentration.
conclusionThese findings prove the therapeutic clinical equivalence as well the PK equivalence of the generic LDB and the originator (Madopar).
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