Trial reportDrugs in R&D2025
Bioequivalence Study of Bedaquiline and Sirturo
Trial report in Drugs in R&D, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
BACKGROUND AND
objectiveMultidrug-resistant tuberculosis remains a major global health challenge, and bedaquiline has become an essential drug for its treatment. However, the high cost of the originator product Sirturo
methodsThis study comprised a single-dose, open-label, randomized, crossover trial that was independently conducted under two conditions: fasting and postprandial. All subjects were randomized to receive the single-dose subject formulation and the reference formulation in two separate cycles. Plasma samples were collected at multiple timepoints after dosing and bedaquiline concentrations were determined by a validated ultra-performance liquid chromatography-tandem mass spectrometry method. Key pharmacokinetic parameters including maximum plasma concentration and area under the plasma concentration-time curve from time 0 to 72 h were calculated using a non-atrial model and bioequivalence was assessed using analysis of variance and 90% confidence intervals.
resultsA total of 40 cases were included in the fasting group and 50 healthy subjects in the postprandial group. The geometric mean ratio of the single-dose subject formulation to the reference formulation within both groups fell within the 80.00-125.00% bioequivalence range for the 90% confidence interval of maximum plasma concentration to area under the plasma concentration-time curve from time 0 to 72 h. Overall drug exposure levels (area under the plasma concentration-time curve) were higher in the postprandial state than in the fasting state, but the subject formulation remained consistent with the reference formulation. All subjects completed the study and no serious adverse events were observed.
conclusionsBedaquiline fumarate tablets of Zhejiang Haizheng Pharmaceutical Co., Ltd. showed good bioequivalence and tolerability with Sirturo CLINICAL
trial registrationChiCTR2500105414.
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