None listed
Conditions
Interventions
Intervention1: Esaxerenone Tablet 5 mg Mfg by Eris Lifesciences Limited
: After overnight fasting of at least 10.00 hours, a single dose of Esaxerenone 5 mg Tablet (T) Manufactured by Eris Lifescience
Sponsors
Eris Lifesciences Ltd
Eris Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy human subjects, age in the range of 18 - 45 years both inclusive. (2) Body Mass Index between 18.5-30.0 Kg / m2 extremes included with minimum of 50 kg weight. (3) Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature). (4) Subjects with clinically acceptable findings as determined by haemogram, biochemistry, including serum sodium, Serum potassium, urinalysis, 12 lead ECG and chest X-ray (if done) (5) Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until the last blood sample collection in each study period and adherence to food, fluid and posture restrictions. (6) No history of significant alcoholism. (7) No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months. (8) Non-smokers as evident from the history obtained will be included. (9) Willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Known history of hypersensitivity to Esaxerenone or related drugs or any of the excipients. (2) Subject having hyperkalemia during the screening. (3) Subject with Systolic BP less than 110 of mmHg and / or diastolic BP less than 70 mmHg during screening. (4) Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. (5) Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IP. (6) Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc. (7) History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases. (8) Participation in a clinical drug study, bioequivalence study and blood donation 90 days prior to period-I dosing of the present study. (9) Smokers, or who have smoked within last six months prior to start of the study. (10) History of malignancy or other serious diseases. (11) Subjects with positive HIV tests, HBsAg or Hepatitis-C tests. (12) Found positive in breath alcohol test and urine test for drug abuse. (13) History of problem in swallowing of tablet/capsule. (14) Any contraindication to blood sampling. (15) Female subjects found positive serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test. (16) Lactating women (currently breast feeding). (17) Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable. (18) Male subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable. (19) Use of hormonal contraceptives either oral or implants. Note: The rationale for exclusion criteria 16 and 18 is provided in section 4.3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-8,Timepoint: Total number of blood samples: 23 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.33, 04.67, 05.00, 06.00, 08.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hrs. Blood samples will be collected in K2EDTA Vacutainer. Note: Blood Sample collection will be performed under Sodium Vapor Light condition. | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC% extrapolation, Kel, Tmax and t1/2 Timepoint: Total number of blood samples: 23 samples per period. Sampling hrs: Pre dose [(5 mL) collected within 01.00 hour prior to dosing] and post dose of 3 mL at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.33, 04.67, 05.00, 06.00, 08.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hrs. Blood samples will be collected in K2EDTA Vacutainer. Note: Blood Sample collection will be performed under Sodium Vapor Light condition. | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Eris Lifesciences Ltd.
Outcome results
None listed