Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK3542503 · 1 trial · 1 indication
Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent confidence intervals (CIs) for estimates of the geometric mean ratios between the AUC (0-t) of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.
Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between the Cmax of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.
| Arm | Type | Description |
|---|---|---|
| Test A followed by Ref B of HCTZ 50mg+ Amiloride HCl 5mg | EXPERIMENTAL | Eligible participants following an overnight fast of at least 10 hours, will be administered the study drug orally with 240 mL (8 fluid ounces) of water. No food will be allowed for at least 4 hours post-dose. Water will be allowed as desired except for one hour before and after drug administration. |
| Ref B followed by test A of HCTZ 50mg + Amiloride HCl 5mg | EXPERIMENTAL | Eligible participants following an overnight fast of at least 10 hours, will be administered the study drug orally with 240 mL (8 fluid ounces) of water. No food will be allowed for at least 4 hours post-dose. Water will be allowed as desired except for one hour before and after drug administration. |
| Name | Type | Description |
|---|---|---|
| GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets) | DRUG | 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. |
| Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets) | DRUG | Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets) tablets are peach-colored, half scored, diamond shaped tablets marked "MSD917". |
Inclusion Criteria: * Participants must be between18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy, non-smoker, as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, la...
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GSK3542503 is an investigational fixed-dose combination tablet containing hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg. It is being developed by GSK plc for hypertension, a cardiovascular condition. The product is a small molecule combination and has been studied in a Phase 1 bioequivalence trial in healthy adult participants.
GSK3542503 is being developed for the treatment of hypertension. It combines hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg in a single tablet. The clinical program to date has focused on establishing bioequivalence rather than testing blood pressure lowering in patients with hypertension.
GSK3542503 is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program for this hydrochlorothiazide and amiloride hydrochloride combination product.
GSK3542503 is in Phase 1 development. Its single registered trial, NCT03031496, was a Phase 1 bioequivalence study and is now completed. The drug is investigational and has not been approved for marketing.
GSK3542503 has been studied in one clinical trial, NCT03031496, titled a bioequivalence study between GSK3542503 hydrochlorothiazide plus amiloride hydrochloride 50 mg: 5 mg tablets and a reference product in healthy adult participants under fasting conditions. The Phase 1 trial enrolled 42 participants in South Africa and is completed.