The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants aged 18 to 45 years, inclusive. Study details include: The study duration will be approximately 40 days. The treatment period will be up to 8 days. At least 3 days post-treatment follow-up period. end of study: 6±1 days from the last dose. The number of visits will be 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Oral suspension-Route of administration:Oral
AUClast
Area under the plasma concentration versus time curve until the time of last quantifiable concentration
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
Cmax
Maximum plasma concentration observed
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
tmax
Time to reach Cmax
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
t1/2z
Terminal half-life associated with the terminal slope (λz)
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
tlag
Interval between administration time and the sampling time preceding the first concentration above the limit of quantification
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
AUC
Area under the plasma concentration versus time curve extrapolated to infinity
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
AUClast/AUC
AUClast/AUC ratio
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
λz
slope of the regression line of the observed terminal phase of the concentration versus time curve
Time frame: Baseline (H0) to Day 3 (H48) for each of the 2 periods
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