A clinical trial to study the effect of food on the blood levels of aliskiren, amlodipine and hydrochlorothiazide when the combination drug product containing these three drugs is administered with food

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: Aliskiren + Amlodipine+ Hydrochlorothiazide: 300/10/25 mg Control Intervention1: NIL: NIL CONDITION: Healthy Subjects (Formulation Development) PRIMARY OUTCOME: To determine the effect of food on the pharmacokinetics of aliskiren, amlodipine and hydrochlorothiazide following single oral dose of fixed dose combination of aliskiren/; amlodipine/ hydrochlorothiazide 300/10/25 mg tablet under fasted and fed condition.‐‐‐‐‐‐Timepoint: Single dose of SAH100 administration under fasting or fed condition followed by PK sample collection till day 8 (except on Day 6) SECONDARY OUTCOME: To assess the safety and tolerability of a single oral dose of the fixed combination of aliskiren/ amlodipine/ hydrochlorothiazide 300/10/ 25 mg tablet under fasted and fed condition.‐‐‐‐‐‐Timepoint: Number of AEs from first dosing to end of study evaluation and number of SAEs from date of ICF to 4weeks after last dose administration INCLUSION CRITERIA: Healthy male and female subjects ( women of non‐child bearing potential)
Epistemonikos ID: f0f74e1ee6029dc409636703697913f63e1e2e38
First added on: Aug 22, 2024