OBJECTIVE: To compare the bioavailability of oral and intramuscular (i.m.) dexamethasone in third-trimester pregnant women. METHODS: Oral and i.m. dexamethasone levels were compared in a randomized, parallel, crossover bioavailability study involving 11 gravid women in the third trimester of pregnancy. Subjects were randomized to receive either 6 mg of i.m. or 8 mg of oral dexamethasone. The following week, the alternative regimen was administered. Serial blood samples were obtained after drug administration. Dexamethasone concentrations were measured by radioimmunoassay. Total area under the curve was compared for the oral and i.m. groups using a paired t test. RESULTS:Eight of the 11 women completed the study through 12 hours; all 11 women completed the study through 6 hours. Among the 11 women, peak levels of dexamethasone occurred 30 minutes after i.m. injection (mean +/- standard deviation, 101.7 +/- 19.2 ng/mL) and 120 minutes after oral administration (65.9 +/- 20.5 ng/mL). Area under the curve did not differ significantly between those receiving i.m. dexamethasone (258.3 +/- 50.0 ng/minute/mL) and those receiving oral dexamethasone (251.8 +/- 59.7 ng/minute/mL) when measured 6 hours after administration of the drug. Terminal half-lives were similar in the i.m. and oral groups. Similar findings were noted among the eight women who were studied through 12 hours. This study had a power of 87% to detect a 20% difference in area under the curve between the two groups. CONCLUSION: The bioavailability of 8 mg of oral dexamethasone is similar to that of a 6-mg IM dose, as determined by the area under the curve.
RCT Entities:
OBJECTIVE: To compare the bioavailability of oral and intramuscular (i.m.) dexamethasone in third-trimester pregnant women. METHODS: Oral and i.m. dexamethasone levels were compared in a randomized, parallel, crossover bioavailability study involving 11 gravid women in the third trimester of pregnancy. Subjects were randomized to receive either 6 mg of i.m. or 8 mg of oral dexamethasone. The following week, the alternative regimen was administered. Serial blood samples were obtained after drug administration. Dexamethasone concentrations were measured by radioimmunoassay. Total area under the curve was compared for the oral and i.m. groups using a paired t test. RESULTS: Eight of the 11 women completed the study through 12 hours; all 11 women completed the study through 6 hours. Among the 11 women, peak levels of dexamethasone occurred 30 minutes after i.m. injection (mean +/- standard deviation, 101.7 +/- 19.2 ng/mL) and 120 minutes after oral administration (65.9 +/- 20.5 ng/mL). Area under the curve did not differ significantly between those receiving i.m. dexamethasone (258.3 +/- 50.0 ng/minute/mL) and those receiving oral dexamethasone (251.8 +/- 59.7 ng/minute/mL) when measured 6 hours after administration of the drug. Terminal half-lives were similar in the i.m. and oral groups. Similar findings were noted among the eight women who were studied through 12 hours. This study had a power of 87% to detect a 20% difference in area under the curve between the two groups. CONCLUSION: The bioavailability of 8 mg of oral dexamethasone is similar to that of a 6-mg IM dose, as determined by the area under the curve.
Authors: Augusto F Schmidt; Matthew W Kemp; Mark Milad; Lisa A Miller; James P Bridges; Michael W Clarke; Paranthaman S Kannan; Alan H Jobe Journal: PLoS One Date: 2019-09-19 Impact factor: 3.240
Authors: Augusto F Schmidt; Alan H Jobe; Paranthaman S Kannan; James P Bridges; John P Newnham; Masatoshi Saito; Haruo Usuda; Yusaku Kumagai; Erin L Fee; Michael Clarke; Matthew W Kemp Journal: Pediatr Res Date: 2019-07-31 Impact factor: 3.756