Bioequivalence Study of Atenolol Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions.
Clin Pharmacol Drug Dev
; 13(8): 870-875, 2024 Aug.
Article
in En
| MEDLINE
| ID: mdl-38742472
ABSTRACT
Atenolol, a cardioselective ß1-blocker, exhibits efficacy in treating cardiovascular diseases. We conducted a single-center, randomized, open, single-dose, 2-preparation, 2-cycle, 2-sequence, double-crossover trial with a 7-day washout period to investigate the pharmacokinetics, bioequivalence (BE), and safety of test and reference atenolol tablets (25 mg) in healthy Chinese volunteers. Forty-eight healthy participants were randomized into the fasting and fed arms. After administering a single oral dose of the test or reference formulation (25 mg), plasma atenolol concentrations were measured using liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were obtained from concentration-time profiles. In total, 23 and 24 individuals were included in the fasting and fed arms, respectively. The mean concentration-time profiles for both formulations were similar, and Cmax, AUC0-t, and AUC0-∞ were within the BE range of 80%-125%. Thirteen adverse events (AEs) were observed in 7 participants in the fasting arm; 1 withdrew from the trial early owing to an AE. In the fed arm, 20 AEs were observed in 8 participants, and none withdrew from the trial. All adverse reactions were grade I, with no serious AEs or deaths. Therefore, the 2 tablets are bioequivalent in healthy Chinese individuals under fasting and fed conditions, supporting their further clinical development.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Atenolol
/
Tablets
/
Therapeutic Equivalency
/
Fasting
/
Cross-Over Studies
/
Area Under Curve
/
Healthy Volunteers
Limits:
Adult
/
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
En
Journal:
Clin Pharmacol Drug Dev
/
Clinical pharmacology in drug development
/
Clinical pharmacology in drug development (Online)
Year:
2024
Type:
Article
Affiliation country:
China