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ORIGINAL RESEARCH

Comparative Pharmacokinetics and Safety of Imrecoxib, a Novel Selective Cyclooxygenase-2 Inhibitor, in Elderly Healthy Subjects

ORCID Icon, , , , , & show all
Pages 3865-3876 | Received 25 Aug 2022, Accepted 23 Oct 2022, Published online: 05 Dec 2023

Figures & data

Figure 1 The major metabolic process of imrecoxib.

Figure 1 The major metabolic process of imrecoxib.

Figure 2 The flowchart of the study.

Figure 2 The flowchart of the study.

Table 1 Demographics of Enrolled Subjects

Figure 3 Typical chromatograms of imrecoxib (M0), M1, M2 and IS. (AD) Chromatograms of M1 and IS in (A) blank plasma; (B) blank plasma containing IS; (C) blank plasma containing M1 and IS at their LLOQ values; and (D) the plasma sample collected 1h after an oral administration of 100 mg imrecoxib. (EH) Chromatograms of M0, M2 and IS in (E) blank plasma; (F) blank plasma containing IS; (G) blank plasma containing M0, M2 and IS at their LLOQ values; and (H) the plasma sample collected 1h after an oral administration of 100 mg imrecoxib. Peaks I–IV shows imrecoxib (M0), M1, M2 and IS (BAP385), respectively.

Abbreviations: IS, internal standard; LLOQ, lower limit of quantitation.
Figure 3 Typical chromatograms of imrecoxib (M0), M1, M2 and IS. (A–D) Chromatograms of M1 and IS in (A) blank plasma; (B) blank plasma containing IS; (C) blank plasma containing M1 and IS at their LLOQ values; and (D) the plasma sample collected 1h after an oral administration of 100 mg imrecoxib. (E–H) Chromatograms of M0, M2 and IS in (E) blank plasma; (F) blank plasma containing IS; (G) blank plasma containing M0, M2 and IS at their LLOQ values; and (H) the plasma sample collected 1h after an oral administration of 100 mg imrecoxib. Peaks I–IV shows imrecoxib (M0), M1, M2 and IS (BAP385), respectively.

Table 2 Results of Plasma Pharmacokinetics of Imrecoxib (M0), M1 and M2

Figure 4 Individual and mean plasma concentration-time curves of imrecoxib (M0), M1 and M2. (A) The individual plasma concentration-time curves of M0, M1 and M2 in the non-elderly group (A1–A10). (B) The individual plasma concentration–time curves of M0, M1 and M2 in the elderly group (B1–B9). (C) The mean plasma concentration–time curves of M0, M1 and M2 in the non-elderly group (A) and elderly group (B).

Figure 4 Individual and mean plasma concentration-time curves of imrecoxib (M0), M1 and M2. (A) The individual plasma concentration-time curves of M0, M1 and M2 in the non-elderly group (A1–A10). (B) The individual plasma concentration–time curves of M0, M1 and M2 in the elderly group (B1–B9). (C) The mean plasma concentration–time curves of M0, M1 and M2 in the non-elderly group (A) and elderly group (B).

Table 3 Geometric Mean Ratio and Its 90% CI of Main Pharmacokinetic Parameters of Imrecoxib (M0), M1 and M2

Table 4 Summarization of All the Adverse Events