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Bioequivalence of cefdinir capsules in Chinese healthy population under fasting/high-fat fed condition / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics ; (12): 740-745, 2020.
Article in Chinese | WPRIM | ID: wpr-855807
ABSTRACT

AIM:

To evaluate the bioequivalence and safety of two cefdinir capsules under a fasting/high-fat fed condition in healthy people.

METHODS:

Twenty-six healthy volunteers were randomized to cross-test single-dose oral cefdinir capsules or reference preparations for fasting. Thirty-six healthy volunteers were randomized to crossed single-dose oral cefdinir capsule test preparations or reference preparations after high-fat meals. The blood concentration of cefdinir was determined by liquid chromatography-mass spectrometry (LC-MS/MS). Pharmacokinetic parameters and equivalence were calculated and evaluated using WinNonlin 6.4 and SAS 9.4 software.

RESULTS:

The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by twenty-five healthy volunteers for fasting were 93.01%-109.22%, 96.16%-110.06%, and 96.38%-110.16%, all at 80.00%-125.00% within the range of bioequivalence. The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by thirty-six healthy volunteers for a high-fat fed were 93.91%-103.28%, 92.93%-100.72% and 92.97%-101.26%, all at 80.00%-125.00% within the range of bioequivalence. The incidences of adverse reactions in healthy volunteers taking cefdinir capsules for the fasting test and reference preparations were 12.0% and 11.5%, respectively. The incidence of adverse reactions in healthy volunteers taking cefdinir capsules after the meal was 25.0% and 27.8%, respectively.

CONCLUSION:

The test preparation of cefdinir capsules and the reference preparation are bioequivalent, and the volunteers show good safety and tolerability under the test dose.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Clinical Pharmacology and Therapeutics Year: 2020 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Clinical Pharmacology and Therapeutics Year: 2020 Type: Article