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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | de Kam, Pieter-Jan Hou, Jie Wang, Zaiqi Lin, Wen Hong Van Den Heuvel, Michiel |
| Spatial Coverage | China |
| Abstract | OBJECTIVE: Elimination of sugammadex occurs predominantly via the kidneys, with the majority of the drug excreted unchanged in the urine. To date, most studies with sugammadex have been performed in non-Asian populations. The objectives of this open-label study were to determine the pharmacokinetics (PK) and safety of single-dose sugammadex (16 mg/kg) in healthy Chinese adult volunteers. METHODS: 12 Chinese subjects (6 male; 6 female) received intravenous sugammadex (16 mg/kg) as a 10-second bolus infusion. Blood samples were collected pre-sugammadex and at regular intervals up to 24 hours post-sugammadex for PK assessment. Safety was assessed via AEs, vital signs, electrocardiogram, and laboratory parameters. RESULTS: Following sugammadex 16 mg/kg infusion, peak sugammadex concentration was 197 µg/mL, clearance was 99.7 mL/min, and apparent volume of distribution at equilibrium was 10.5 L. Plasma sugammadex concentrations showed a polyexponential decline over time, with an overall geometric mean (CV%) terminal half-life of 145 minutes (17.9%) (139 minutes (17.7%) for males; 152 minutes (18.6%) for females). No influence of gender on the PK of sugammadex was observed. Three subjects experienced an adverse events (AE) (dysgeusia of mild intensity), which was considered possibly or probably related to sugammadex. There were no clinically significant changes in vital signs, electrocardiography or laboratory parameters. CONCLUSION: PK of sugammadex (16 mg/kg) was characterized in healthy Chinese subjects. Overall between-subject variability on clearance and apparent volume of distribution was ~ 10%. Sugammadex was generally well tolerated. |
| File Format | HTM / HTML |
| ISSN | 09461965 |
| Issue Number | 6 |
| Volume Number | 53 |
| Journal | Int. Journal of Clinical Pharmacology and Therapeutics |
| Language | English |
| Publisher | Dustri-Verlag |
| Publisher Date | 2015-06-01 |
| Publisher Place | Germany |
| Access Restriction | Subscribed |
| Subject Keyword | Discipline Pharmacology Neuromuscular Agents Administration & Dosage Pharmacokinetics Gamma-cyclodextrins Area Under Curve Asian Continental Ancestry Group China Drug Monitoring Female Half-life Healthy Volunteers Humans Infusions, Intravenous Male Metabolic Clearance Rate Adverse Effects Blood Risk Assessment Young Adult Clinical Trial Journal Article |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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