Error in Table
In the original publication [
1], there was a transcription error of the oral midazolam (Table 2) and intravenous (Table S1) area under the curve (AUC) values. The corrected
Table 2 and
Table S1 appear below.
Table 2.
Endogenous and exogenous CYP3A markers in men before and after the repeated administration of ITZ/FKZ/APZ, including ratios of treatment/baseline.
Table S1.
Effect of alprazolam (1 mg) on midazolam and 1′-hydroxymidazolam pharmacokinetics following single dose administration (1.5 mg p.o or 1 mg i.v) in healthy participants (n = 10).
Updating Conflicts of Interest Statement
In the original publication [1], the Conflict of Interest declaration did not fully reflect the required disclosure of conflicts of interest. The corrected Conflict of Interest appear below.
Conflicts of Interest: Authors X.-Q.L. and T.B.A. were employed by the company AstraZeneca. Authors C.M. and R.S.T. were employed by the African Institute of Biomedical Science and Technology (AiBST). The authors declare that this study received funding from AstraZeneca and institutional infrastructure and operations support from AiBST. The funder had the following involvement with the study: the conception & design, the analysis, interpretation of data, the writing of this article.
The authors state that the scientific conclusions are unaffected. This correction was approved by the Academic Editor. The original publication has also been updated.
Reference
- Li, X.-Q.; Thelingwani, R.S.; Bertilsson, L.; Diczfalusy, U.; Andersson, T.B.; Masimirembwa, C. Evaluation of 1β-Hydroxylation of Deoxycholic Acid as a Non-Invasive Urinary Biomarker of CYP3A Activity in the Assessment of Inhibition-Based Drug–Drug Interaction in Healthy Volunteers. J. Pers. Med. 2021, 11, 457. [Google Scholar] [CrossRef] [Scilit] [PubMed]
Table 2.
Endogenous and exogenous CYP3A markers in men before and after the repeated administration of ITZ/FKZ/APZ, including ratios of treatment/baseline.
| | Baseline | Treatment | Last Washout | Treatment/Baseline (90%CI) | Ratio (90%CI) |
|---|
| ITZ (100 mg od) |
| 1β-OH-DCA/ToDCA | 0.15 (0.04–0.50) | 0.04 (0.01–0.10) | 0.17 (0.05–0.45) | 0.25 *** (0.18–0.34) | |
| Oral MDZ CL | 126 (46.7–648.8) | 37.1 (10.5–79.5) | 80.5 (34.8–211.6) | 0.30 ** (0.18–0.47) | 0.83 (0.43–1.61) |
| Oral MDZ AUC0-inf | 10.8 (2.1–29.1) | 36.6 (17.1–129.0) | 16.9 (6.4–38.9) | 3.40 ** (2.11–5.45) | |
| i.v. MDZ CL | 82.9 (48.6–162.1) | 36.1 (6.0–111.4) | 120 (62.2–262.5) | 0.44 * (0.26–0.73) | 0.56 (0.35–0.92) |
| i.v. MDZ AUC0-inf | 12.1 (6.17–20.6) | 27.7 (9.0–167.4) | 9.8 (3.8–16.1) | 2.30 * (1.37–3.86) | |
| FKZ (50 mg od) |
| 1β-OH-DCA/ToDCA | 0.17 (0.12–0.27) | 0.14 (0.07–0.26) | 0.18 (0.10–0.42) | 0.86 (0.71–1.03) | |
| Oral MDZ CL | 59.8 (17.0–135.9) | 44.0 (14.8–85.2) | 104 (57.6–331.9) | 0.74 (0.53–1.02) | 1.17 (0.84–1.63 |
| Oral MDZ AUC0-inf | 22.7 (10.0–79.6) | 30.8 (15.9–91.5) | 13 (4.1–23.5) | 1.36 (0.98–1.89) | |
| i.v. MDZ CL | 80.7 (46.3–276.0) | 38.3 (14.4–78.5) | 95.1 (46.9–213.4) | 0.47 * (0.260–0.866) | 1.81 (0.90–3.63) |
| i.v. MDZ AUC0-inf | 12.4 (3.6–21.6) | 26.1 (12.7–69.47) | 10.5 (4.7–21.3) | 2.11 * (1.16–3.85) | |
| APZ (1 mg od) |
| 1β-OH-DCA/ToDCA | 0.16 (0.09–0.46) | 0.20 (0.10–0.84) | 0.18 (0.08–0.32) | 1.24 (0.88–1.74) | |
| Oral MDZ CL | 59.1 (28.0–220.5) | 48.6 (23.7–102.2) | 63.6 (38.2–220.5) | 0.82 (0.57–1.19) | 1.51 (1.02–2.21) |
| Oral MDZ AUC0-inf | 10.56 (6.04–18.49) | 8.67 (5.12–14.69) | 8.39 (3.81–18.47) | 0.80 (0.54–1.18) | |
| i.v. MDZ CL | 59.6 (23.3–185.9) | 38.1 (21.5–55.5) | 53.7 (24.8–81.8) | 0.64 (0.400–1.023) | 1.94 * (1.16–3.22) |
| i.v. MDZ AUC0-inf | 16.78 (5.38–42.8) | 26.25 (18.01–46.44) | 18.6 (12.2–40.3) | 1.56 (0.98–2.50) | |
Table S1.
Effect of alprazolam (1 mg) on midazolam and 1′-hydroxymidazolam pharmacokinetics following single dose administration (1.5 mg p.o or 1 mg i.v) in healthy participants (n = 10).
| Parameter | Geometric Mean Values (90% CI) | Geometric Mean Ratio (90% CI) | p-Value |
|---|
| MDZ Alone | MDZ + APZ |
|---|
| MDZ |
| i.v | AUC0–∞ (ng·h/mL) | 16.78 (11.16–25.24) | 26.25 (21.18–32.53) | 156 (102–240) | 0.09 |
| AUClast (ng·h/mL) | 16.64 (11.04–25.07) | 24.57 (18.67–32.22) | 148 (93–234) | 0.12 |
| Cmax (ng/mL) | 25.98 (12.75–52.93) | 50.71 (44.81–55.95) | 193 (99–377) | 0.02 |
| Tmax (h) | 0.29 (0.22–0.37) | 0.30 (0.24–0.37) | | |
| T1/2 (h) | 2.06 (1.62–2.61) | 3.73 (1.80–7.73) | | |
| CL (L/h) | 59.88 (39.62–89.50) | 38.09 (30.73–47.20) | | |
| p.o. | AUC0–∞ (ng·h/mL) | 10.56 (6.04–18.49) | 8.67 (5.12–14.69) | 80 (54–118) | 0.30 |
| AUClast (ng·h/mL) | 10.43 (7.84–13.86) | 10.85 (3.92–6.45) | 104 (71–153) | 0.23 |
| Cmax (ng/mL) | 4.13 (3.33–5.11) | 5.03 (3.92–6.45) | 122 (89–166) | 0.07 |
| Tmax (h) | 0.76 (0.60–0.95) | 1.03 (0.81–1.31) | | |
| T1/2 (h) | 1.63 (1.01–2.62) | 1.47 (1.11–1.95) | | |
| CL (L/h) | 137.34 (101–186) | 136.46 (101–184) | | |
| 1′-OH-MDZ |
| i.v | AUC0–∞ (ng·h/mL) | 4.49 (2.12–9.50) | 2.25 (1.07–4.72) | 49 (18–100) | 0.03 |
| AUClast (ng·h/mL) | 2.54 (1.49–4.35) | 1.81 (0.84–3.86) | 71 (28–179) | 0.26 |
| Cmax (ng/mL) | 1.24 (1.02–1.50) | 1.06 (0.88–1.27) | 85 (67–109) | 0.09 |
| Tmax (h) | 0.81 (0.65–1.10) | 0.77 (0.66–0.89) | | |
| T1/2 (h) | 2.21 (0.89–5.49) | 1.15 (0.61–2.18) | | |
| CL (L/h) | - | - | | |
| p.o. | AUC0–∞ (ng·h/mL) | 10.56 (6.77–16.48) | 9.19 (5.76–14.69) | 87 (48–157) | 0.16 |
| AUClast (ng·h/mL) | 8.23 (6.15–11.02) | 4.90 (3.53–6.80) | 60 (40–89) | 0.01 |
| Cmax (ng/mL) | 2.60 (2.13–3.18) | 1.70 (1.44–2.01) | 65 (52–83) | 0.01 |
| Tmax (h) | 0.77 (0.65–0.91) | 1.03 (0.84–1.27) | | |
| T1/2 (h) | 2.54 (1.26–5.09) | 4.83 (2.41–9.66) | | |
| CL (L/h) | - | - | | |
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