Table 1.
Participant Demographics and Baseline Characteristics
| Demographic/Characteristic | Total N = 26 a |
|---|---|
| Age, y | |
| Mean (SD) | 56 (5.1) |
| Range, min‐max | 45‐64 |
| Race, n (%) | |
| White | 23 (88.5) |
| Black or African American | 1 (3.8) |
| American Indian/Alaska Native | 1 (3.8) |
| Native Hawaiian/Pacific Islander | 1 (3.8) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 10 (38.5) |
| Not Hispanic or Latino | 16 (61.5) |
| BMI, kg/m2 | |
| Mean (SD) | 26.4 (2.5) |
| Median (min‐max) | 26.4 (19.1‐30.1) |
| Creatinine clearance, b L/h | |
| Mean (SD) | 101.7 (14.7) |
| Median (min‐max) | 99.0 (81.0‐136.0) |
BMI indicates body mass index; max, maximum; min, minimum.
Of these 26 enrolled participants, 4 discontinued. One withdrew for personal reasons on day –1 of period 2; 1 withdrew for a family emergency on day 8 of period 2; 1 withdrew for a family emergency on day 14 of period 2; and 1 was removed from the study by the investigator on day 9 of period 2 for adverse events considered unrelated to the study drugs.
Creatinine clearance was calculated with the Cockcroft‐Gault equation as follows: Creatinine Clearance = (140 – Age [y]) × (Body Weight [kg])/72 × (Serum Creatinine [mg/dL]), where body weight is the weight collected at screening, serum creatinine is the average of the values collected at screening and check‐in, and the result is multiplied by 0.85, as all participants were female.