None listed
Conditions
Interventions
Intervention1: Test product - Venetoclax Tablets 100 mg by Hydrogen company for pharmaceutical productions and industrial investments.: In each period high fat high calorie breakfast will be served to
Sponsors
Hydrogen company for pharmaceutical productions and industrial investments
ICBio Clinical Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 2) Willing to be available for the entire study period and to comply with protocol requirements. 3) Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age. 4) Body mass index in the range of 18.5 30.0 kg-m2 (both inclusive). 5) Healthy volunteers who are clinically non anemic will be included as per the discretion of PI-CI-Physician. 6) Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period. 7) With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis. 8) With a normal or clinically non-significant 12-lead ECG. 9) With a negative test for Human Immunodeficiency Virus (HIV) type I-II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 10) Non-smokers and willing to abstain from smoking or chewing any tobacco containing product for at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points. 11) Male volunteer willing to use appropriate contraceptive measures to ensure that his female partner will not get pregnant for at least 15 days before 1st dosing till 15 days post last-dose- entire study period. 12) In case of female subjects: 13) Negative urine pregnancy test during screening and negative serum beta-hCG test at check-in of each study period. 14) Female subjects with childbearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse or using acceptable methods of birth control for at least 15 days before 1st dosing till 15 days post last-dose-entire study period (Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) has been performed). 15) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
Exclusion criteria
Exclusion criteria: 1) Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs. 2) History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past along with chronic lymphocytic leukemia and small cell lymphocytic leukemia. 3) History of severe infection or major surgery in the past 6 months. 4) History of Minor surgery or fracture within the past 3 months. 5) Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 6) Any major illness or hospitalization within 90 days prior to check-in of first period. 7) Subjects who have been on an unusual diet with low sodium intake or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 8) Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 9) Use of any prescribed medication (including herbal medicines and vitamin supplements) for at-least 30 days prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 10) Use of any OTC products for at-least 14 days prior to first check-in and throughout the duration of the study until the post study safety sample is collected. 11) Use of any strong CYP3A inhibitors and preparations containing St. John s wort. 12) Use of any recreational drug or history of drug addiction. 13) Participated in any clinical investigation requiring repeated blood sampling, blood donation, or otherwise leading to blood loss of equal to or more than 500 ml in past 90 days prior to first check-in. 14) Participated in any clinical study within the past 90 days prior to check-in. 15) Consumption of alcohol or alcoholic products for at-least 48.00 hrs prior to check-in in each study period and throughout sampling time points. 16) Positive alcohol breath or urine screening for drug of abuse tests during check-in in each study period. 17) Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) for at-least 48.00 hours prior to check-in in each study period and throughout sampling time points. 18) Consumption of grapefruit or its juice for at-least 72.00 hours prior to check-in in each study period and throughout sampling time points. 19) Lactating or nursing female subjects and female subjects who are planning for the pregnancy during the tenure of this study period. 20) Female subjects using hormonal contraceptive (either oral/implants). 21) History of allergy or hypersensitivity or intolerance to Venetoclax or its formulation excipients which, in the opinion of the PI/CI/Physician, would compromise the safety of the subject or the study. 22) History of diff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Venetoclax Tablets 100 mg by Hydrogen company for pharmaceutical productions and industrial investments with Venclyxto 100 mg film-coated tablets (Venetoclax) of AbbVie Deutschland GmbH & Co. Germany in healthy adult human subjects under fed conditionsTimepoint: To compare the rate and extent of absorption of Venetoclax Tablets 100 mg by Hydrogen company for pharmaceutical productions and industrial investments with Venclyxto 100 mg film-coated tablets (Venetoclax) of AbbVie Deutschland GmbH & Co. Germany in healthy adult human subjects under fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the study subjects after administration of Venetoclax Tablets 100 mg in healthy, adult, human subjects under fed condition.Timepoint: Vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) measurement station Before check-in and at pre-dose (within 2.00 hrs before dosing), at 3.00, 07.00 and 11.00 hrs after dosing (within 40 min of scheduled time of recording), at the time of check-out in each period and ambulatory visit in each period. The well-being of subjects will be ascertained at each vital sign measurement. | — |
Countries
India
Contacts
Public ContactDr Lakshmikar B V
ICBio Clinical Research Private limited
Outcome results
None listed