Comparative assessment of the absorption of a generic formulation of 5-O-ethyl 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate extended release tablet against the innovator 5-O-ethyl 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate extended release tablet conducted under fasting conditions in healthy male and female volunteers

INTERVENTION: The intervention for this trial is the test formulation of 1 X2.5 mg 5‐O‐ethyl 3‐O‐methyl 4‐(2,3‐dichlorophenyl)‐2,6‐dimethyl‐1,4‐dihydropyridine‐3,5‐dicarboxylate extended release tablet given once only. Each dose is separated by a one week washout period. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Screening and study exit laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure that the medication has been taken as directed. CONDITION: 5‐O‐ethyl 3‐O‐methyl 4‐(2,3‐dichlorophenyl)‐2,6‐dimethyl‐1,4‐dihydropyridine‐3,5‐dicarboxylate is indicated for the treatment of hypertension.; ; 5‐O‐ethyl 3‐O‐methyl 4‐(2,3‐dichlorophenyl)‐2,6‐dimethyl‐1,4‐dihydropyridine‐3,5‐dicarboxylate is indicated for the treatment of hypertension. Cardiovascular ‐ Hypertension PRIMARY OUTCOME: To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the innovator formulation. All plasma samples will be assayed for 5‐O‐ethyl 3‐O‐methyl 4‐(2,3‐dichlorophenyl)‐2,6‐dimethyl‐1,4‐dihydropyridine‐3,5‐dicarboxylate extended release tablet using one fully validated LC/MS/MS method. Validation will be conducted to comply with TGA guidelines.[Pre‐dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 14, 18, 24, 32, 48, 56 and 72 hours post dosing.] SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tma Xwill be the time where the maximum concentration occurred in the sample points.[Pre‐dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 14, 18, 24, 32, 48, 56 and 72 hours post dosing.] INCLUSION CRITERIA: Healthy males and females Aged between 18 and 55 years Non‐smoker BMI greater than or equal to 18 and less than 32 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Drug free as determined by urine drug testing Able to comply with the study restrictions Able to provide written informed consent