Pharmacokinetics and Bioequivalence of Misoprostol Tablets: An Open-Label, Randomized, Single-dose, Crossover Study With Healthy Chinese Volunteers.
LC-MS/MS
bioequivalence
highly variable drug
intra-subject variability
misoprostol acid
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
received:
28
11
2021
accepted:
21
03
2022
pubmed:
30
4
2022
medline:
2
8
2022
entrez:
29
4
2022
Statut:
ppublish
Résumé
Misoprostol is a synthetic prostaglandin E1 derivative that has been used to treat duodenal and gastric ulcers, and to prevent ulcers caused by nonsteroidal anti-inflammatory drugs in many countries. Misoprostol can also be used for medical abortion. This study aimed to investigate the pharmacokinetic profiles of misoprostol tablets (test product) by comparing them with Cytotec (200 μg) (reference product). To assess the bioequivalence between test and reference products, a two-sequence, two-period crossover study was conducted with 48 healthy Chinese subjects enrolled under fasting conditions. A validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay was used to determine the concentration of misoprostol acid in plasma. A mixed model analysis of variance was used to calculate the bioequivalence of pharmacokinetic (PK) parameters. The point estimate of geometric mean ratios with 90% confidence intervals for the maximum observed concentration (C
Substances chimiques
Tablets
0
Misoprostol
0E43V0BB57
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
949-956Informations de copyright
© 2022, The American College of Clinical Pharmacology.
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