NCT03031496View on ClinicalTrials.gov

Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 17, 2017

Primary Completion Date

April 10, 2017

Study Completion Date

April 10, 2017

Conditions
Hypertension
Interventions
DRUG

GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets)

"GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets) are cream-colored, circular, flat faced uncoated tablets with beveled edges having break line on one side and BD embossed on the other side."

DRUG

Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)

"Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets) tablets are peach-colored, half scored, diamond shaped tablets marked MSD917."

Trial Locations (1)

9301

GSK Investigational Site, Bloemfontein

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03031496 - Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions | Biotech Hunter | Biotech Hunter