2.15. In Vivo Pharmacokinetic Studies
This protocol is extracted from research article:
Lyophilized Composite Loaded with Meloxicam-Peppermint oil Nanoemulsion for Periodontal Pain
Polymers (Basel), Jul 14, 2021; DOI: 10.3390/polym13142317

The randomized and open-labeled study, in accordance with the Helsinki agreement protocol, was approved by the Ethics Committee of the Beni-Suef Clinical Laboratory Center for clinical studies (Approval No: 07-003-2021), Egypt. The protocol followed a single dose and parallel design with a 1-day study and 14-day screening. A single MX-SNELC corresponding to 7.5 mg MX was provided to the subjects with the direction to keep the MX-SNELC in the oral cavity for 3 min before ingestion. The marketed MX composite (7.5 mg) was provided for oral administration with 250 mL water. Volunteers were directed to remain at the site for 24 h after sample administration for blood sample collection [21]. The data were processed using a non-compartmental model (PK-SOLVER® software), and the desired pharmacokinetic parameters were determined.

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