ArticleEuropean journal of drug metabolism and pharmacokinetics2026
JLP-2008 Fixed-Dose Combination Tablet Demonstrates Bioequivalence and Comparable Safety to Separate Dapagliflozin + Pioglitazone in Healthy Participants.
Article in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06165965 (A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State), which is not on this map. Not yet cited in PubMed.
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A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State
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6 authors.
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Abstract
BACKGROUND AND
objectivesTo establish pharmacokinetic bioequivalence and assess the safety of a single-dose administration of fixed-dose combination (FDC) tablet containing dapagliflozin 10 mg + pioglitazone 15 mg (JLP-2008) compared with a single-dose administration of their individual tablets.
methodsIn this randomized, open-label, two-period crossover study, 49 healthy Korean adults were enrolled, 48 received at least one dose and 45 completed both periods. Participants received either one JLP-2008 tablet or separate dapagliflozin + pioglitazone tablets under fasting conditions, then the alternate treatment after a 7-day washout. Blood samples collected predose to 48 h were quantified by ultra-fast liquid chromatography-tandem mass spectrometry. Primary endpoints were maximum plasma concentration (C
resultsDapagliflozin and pioglitazone met bioequivalence criteria: GMRs (90% CIs) were 1.04 (0.95-1.15) for dapagliflozin C
conclusionJLP-2008 delivers systemic exposures to dapagliflozin and pioglitazone equivalent to those from co-administration of individual tablet and is well tolerated. FDC may provide a more convenient treatment option for patients with type 2 diabetes mellitus (T2DM), and its use was supported by comparable pharmacokinetic and safety profiles. STUDY REGISTRATION: ClinicalTrials.gov (NCT06165965; retrospectively registered on 07 December 2023).
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Registered trials
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