Dataset from An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Fixed Dose Combination Tablets Versus Reference Product in Healthy Adult Participants Under Fasting Conditions

The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ)
(GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and
hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed to
determine whether the test product GSK3542503 is bioequivalent to the reference (ref)
hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult
participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a
phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling
approximately 42 healthy participants at a single center. Study participants will be
randomized to one of two treatment sequences (A-B or B-A) in accordance with the
randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a
hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B
(Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed
dose combination), will be administered on Day 1, in each treatment period. Each participant
will participate in both treatment periods and receive a single dose of each treatment. The
treatment periods will be separated by a washout period of at least 7 days and no more than
14 days. The total duration in the study for each participant is expected to be 5 to 7 weeks,
from screening to his or her last visit. A maximum of 42 participants will be randomized such
that at least 32 evaluable participants complete the study.