Trial reportFrontiers in pharmacology2026
Pharmacokinetics and safety comparison of cycloserine capsules and their generic counterpart: a randomized, open-label, two-period, two-sequence, single-dose crossover bioequivalence study in healthy Chinese subjects.
Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
8 authors.
Funding
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Abstract
Introduction: Cycloserine is a broad-spectrum antibiotic and clinically important second-line anti-tuberculosis agent. This study assessed the bioequivalence of a test cycloserine formulation versus its reference formulation under fasted and fed conditions. Methods: Using a randomized, open-label, two-period, two-sequence crossover design, 64 healthy Chinese participants were enrolled (63 completed). Subjects received a single 250-mg oral dose of both formulations. Bioequivalence was evaluated using plasma concentration-time profiles and key pharmacokinetic (PK) parameters. Statistical analysis employed the Average Bioequivalence (ABE) method. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for C Results: Both formulations exhibited comparable safety profiles. Discussion: Bioequivalence was established between the test and reference cycloserine capsules under fasted and fed states. Clinical Trial Registration: Chinese Clinical Trial Registry (www.chinadrugtrials.org.cn) as (CTR20233940).
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