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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...
GSK3542503 is an investigational small molecule being developed for hypertension, a cardiovascular condition. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its potential use in treating high blood pressure.
GSK3542503 is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with hypertension.
GSK3542503 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of hypertension, and its safety and tolerability are being evaluated in early-stage clinical trials.
GSK3542503 has one completed Phase 1 clinical trial registered under NCT03031496. This study was a bioequivalence trial comparing GSK3542503, a combination of hydrochlorothiazide and amiloride hydrochloride 50 mg:5 mg tablets, to a reference product in healthy adult participants under fasting conditions. The trial enrolled 42 participants in South Africa.
GSK3542503 is a combination product containing hydrochlorothiazide and amiloride hydrochloride. The Phase 1 trial NCT03031496 was designed to assess the bioequivalence of GSK3542503 tablets compared to a reference product of the same combination in healthy volunteers.