ArticleSAGE open medicine2026
A study to evaluate the impact of PB-119 injection (a pegylated exenatide formulation) on the pharmacokinetic profiles of Digoxin and Warfarin sodium in healthy subjects.
Article in SAGE open medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Effect of a Novel GLP-1 Analogue Ecnoglutide on the Pharmacokinetics of Rosuvastatin and Digoxin in Healthy Participants.Diabetes, obesity & metabolism · 2026Article
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Authors and funding
13 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Objective: To evaluate the impact of multiple-dose PB-119 injection (a pegylated exenatide formulation) on the pharmacokinetics of single-dose Digoxin or Warfarin sodium and on the pharmacodynamics of Warfarin sodium in healthy Chinese adults. Methods: This study is a single-centre, open-label, randomized, two-period, two-sequence, parallel-group design phase I clinical trial of drug interactions, aiming to evaluate the pharmacokinetic and pharmacodynamic effects of multiple administrations of PB-119 injection (a pegylated exenatide formulation) on single-dose oral Digoxin and Warfarin sodium in healthy Chinese adults. Sixteen healthy subjects were enrolled in each of two cohorts: Digoxin (Digoxin 0.5 mg versus Digoxin 0.5 mg + PB-119 150 μg) and Warfarin sodium (Warfarin 5 mg versus Warfarin 5 mg + PB-119 150 μg). Treatments were administered in a fixed sequence. The total duration of the study for each subject was 33 days, consisting of a 14-day screening phase (day -14 to day -1), a 9-day inpatient treatment phase (day 1 to day 9 for the Digoxin cohort; day 1 to day 16 for the Warfarin cohort to allow international normalized ratio follow-up), and a 10-day post-treatment safety follow-up (day 10 or day 17 to day 23 or day 30, respectively). Statistical analysis: Pharmacokinetic parameters for Digoxin and Warfarin sodium, as well as pharmacodynamic parameters (INR Results: The rate and extent of absorption of Digoxin or Warfarin sodium administered alone were comparable to those observed when co-administered with PB-119. The 90% confidence intervals of the geometric mean ratios for the primary pharmacokinetic parameters ( Conclusions: Multiple-dose PB-119 injection does neither alter the pharmacokinetic characteristics of single-dose Digoxin or Warfarin sodium, nor does it influence the pharmacodynamic characteristics of Warfarin sodium, in healthy Chinese subjects.
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