Mefenamic acid shows no significant interaction with ciprofol in healthy individuals, which suggests that ciprofol is safe and well tolerated when administered along with mefenamic acid, reports a study.
A team of investigators conducted this single-centre, open-label, two-period drug-drug interaction study in 20 healthy participants, who received ciprofol (0.4 mg kg−1) as a single dose on days 1 and 5. They were also given a 500-mg oral loading dose of mefenamic acid on day 4, followed by a 250-mg maintenance dose every 6 hours (a total of eight doses).
The investigators collected blood samples for PK analyses. They also monitored the depth of anaesthesia using the Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale and Bispectral Index scores (BISs).
Co-administration of ciprofol with mefenamic acid, compared with monotherapy, resulted in no significant difference in exposure.
The geometric mean ratios (GMRs) for maximum plasma concentration (Cmax) was 91.6 percent (95 percent confidence interval [CI], 86.5‒96.9), while the area under the plasma concentration-time curve calculated from 0 to the last measurement point (AUC0-last) and AUC to infinity (AUC0-inf) were 103.3 percent (95 percent CI, 1003‒106.4) and 107.0 percent (95 percent CI, 101.2‒113.2), respectively.
“The MOAA/S and BIS curves for the two treatment periods essentially coincided, indicating that the anaesthesia effect of ciprofol was not affected by mefenamic acid,” the investigators said.
In terms of safety, seven participants (35 percent) experienced a total of eight adverse events (AEs) when ciprofol was administered alone, while 12 reported 18 AEs when ciprofol was administered in combination with mefenamic acid. All AEs reported were mild in severity.