None listed
Conditions
Interventions
Intervention1: Barnidipine Hydrochloride Modified-Release Capsules 20 mg: One capsule will be administered orally with 240 2 mL of water at ambient temperature.
Four period study which is having tot
Sponsors
Centaur Pharmaceuticals Pvt. Ltd., India
CRO LifeSan Clinical Research division of Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy, Indian, male, human volunteers aged from 18 to 45 years (both inclusive). 2. Weight not less than 50 Kg. and body mass index should be within 20.00 29.95 kg/m2 [weight in kg / (height in m)2]. 3. Voluntarily willing and capable to give written and signed informed consent prior to participation in the study. 4. Availability for the entire study period and willingness to adhere to the protocol and study requirements. 5. Willing to undergo pre- and post-study physical examinations and clinical laboratory investigations. 6. Having no current or past significant disease as well as clinically significant observations from medical history or physical examination or vital signs examination during screening. 7. Having normal values or clinically acceptable values of investigations of clinical laboratory examination during screening [exception: SGOT/ SGPT/ S. Alkaline phosphatase and S. total bilirubin, which should be normal]. 8. 12-lead ECG in supine position done as part of screening and admission procedure is within normal limits or showing clinically insignificant artifacts as per qualified medical staff. 9. Normal chest X-ray findings or findings that have no clinical correlation. 10. Determined as eligible through 2-D transthoracic echocardiography conducted within 10 days prior to admission in period I of the study 11. Having not consumed alcohol at least 24.000 hrs. prior to admission in the study justified by negative urine-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study. 12. Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocannabinoids, morphine, cocaine, benzodiazepine). 13. Not consumption of xanthine-containing derivatives [coffee, tea, cola drinks, chocolate] and grapefruit or orange or citrus fruits/ juice/ products for at least 48.000 hrs. prior to admission in the study. 14. Non-smokers [Definition Those who do not have history of smoking or having quit smoking for more than 3 years].
Exclusion criteria
Exclusion criteria: 1. H/O allergy or sensitivity to barnidipine or to any dihydropyridine or history of any drug hypersensitivity or intolerance, which, in the opinion of the investigator, will compromise the safety of the Subject in the study. 2. H/O of rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. 3. History of unstable angina pectoris and acute myocardial infarction. 4. H/O use of strong inhibitors of CYP3A [e.g. antiproteases, ketoconazole, itraconazole, erythromycin and clarithromycin etc.] or inducers of CYP3A [e.g. rifampicin, carbamazepine etc.] at least within 14 days of admission in the study. 5. Clinically significant findings from 2-D transthoracic echocardiography interpreted by the cardiologist. 6. History or presence of hepatic dysfunction established by elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase [at least 1.5 times of upper normal range]. 7. History or presence of renal function impairment established by serum creatinine 1.5 times or more of upper reference range. 8. History or presence of any other clinically relevant systemic disease such as renal, hepatic, pulmonary, endocrine, ophthalmic or metabolic disorder (e.g. diabetes mellitus), malignancy or immunodeficiency disorder. 9. Irregular mealtimes, skipping meals, periods of fasting or dietary changes within last 3 months prior to enrollment in the study. 10. Participation in another clinical study or a blood donation program or having had blood loss of more than 450 mL during the last 90 days. 11. Seropositive for VDRL, HIV or hepatitis B or C infection. 12. Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data, X-ray interpretation, 12-lead ECG and full physical examination 13. Vital sign abnormalities [systolic blood pressure less than 100 or greater than 140 mmHg or diastolic blood pressure less than 60 or greater than 90 mmHg or pulse rate less than 50 bpm or greater than 100 bpm, or oral/axillary temperature less than 95.8 F or greater than 99.0 F at the pre-admission physical examination. 14. Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study. 15. Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug. 16. Having taken OTC or prescribed medications, including any enzyme-modifying drugs or any systemic medication within the last 07 days prior to the study. 17. Having a history of alcohol or substance abuse within the last 5 years. 18. Habit of chewing or inhaling nicotine-containing products. 19. Abnormal INR combined with clinical manifestation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate bioequivalence between two individual Test drug products of Barnidipine Hydrochloride Modified-Release Capsules 20 mg of Centaur Pharmaceuticals Pvt. Ltd. India against Reference drug product of Cyress 20, 20 mg capsules met gereguleerde afgifte (Barnidipine hydrochloride) of BModesto Minervaweg 2 8239 DL Lelystad Netherlands.Timepoint: There is 48 hrs. housing and 02 ambulatory visit in each Period i.e. period I,II,III,IV. Each period will conduct after 14 days of IMP administration. Refer below activity day wise i.e. Day 00 Enrollment, Day 01 Dosing of one capsule of Test1 or Test2 or Reference drug product in each period. Day 03 discharge at 48hrs, Day 04 ambulatory visit 72 hrs sampling time point, Day 05 ambulatory visit 96 hrs. sampling time point after IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the participating Subjects in this bioequivalence study determined by means of hematology, clinical biochemistry, vital signs & physical examination, 12-lead ECG & AE/SAE monitoringTimepoint: There is 48 hrs. housing & 02 ambulatory visit in each Period i.e. period I,II,III,IV. Each period will conduct after 14 days of IMP administration. Refer below activity day wise i.e. Day 00 Enrollment, Day 01 Dosing of one capsule of Test1 or Test2 or Reference drug product in each period. Day 03 discharge at 48hrs, Day 04 ambulatory visit 72 hrs sampling time point, Day 05 ambulatory visit 96 hrs. sampling time point after IMP administration. | — |
Countries
India
Contacts
Public ContactDr Mukund Zarapkar
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Outcome results
None listed