To compare the pharmacokinetics of the test product recombinant asparaginase with the reference product Spectrila® in healthy, adult, subjects.
- Registration Number
- CTRI/2024/05/068025
- Lead Sponsor
- Gennova Biopharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing to provide written informed consent for participation in the study, and able to comprehend the nature and purpose of the study.2.Willing to be available for the entire study period and to comply with the protocol requirements.3.Normal, healthy, adult, human subject of 20-45 years (both inclusive) of age.4.Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive) with minimum of 50 kg weight.5.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in.6.Normal or clinically non-significant laboratory values as determined by haematological, biochemistry tests (serum ALP, serum creatinine, SGOT/AST, SGPT/ALT, serum uric acid; serum bilirubin–total, direct and indirect; total proteins, serum albumin, serum blood urea nitrogen, triglycerides, cholesterol-total, random blood glucose, aPTT, PT, serum amylase, serum lipase) and urine analysis.7.Normal or clinically non-significant 12-lead ECG recording.8.Non-smokers or subjects who have no history of smoking for the last one year prior to check-in.9.Subjects who are willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the study.10.Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until last sample collection.11.Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) and flavonoid containing products at least 48.00 hours prior to check-in until last sample collection.12.Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection.13.For male subjects:
Subjects willing to use adequate contraception during sexual intercourse with female partners of childbearing potential during the study and for a period of 3 months after receiving last dose of IP.14.For female subjects:Negative urine pregnancy test during screening and negative serum hCG test at the time of check-in.Female subjects with childbearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use acceptable birth control methods for at least 15 days before check-in till 3 months post last-dose. [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].
1.Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs.
2.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), haematological, gastrointestinal, dermatological, immunological, or psychiatric diseases, or organ dysfunction.
3.Any major illness or hospitalized within 90 days prior to check-in.
4.Requiring medication for any ailment having enzyme-modifying activity within one month prior to check-in and throughout the study.
5.Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.
6.Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to check-in and throughout the study; history or presence of significant gastric and/or duodenal ulceration.
7.Consumption of St John’s Wort within 14 days prior to check in and throughout the study.
8.Suffering from pancreatitis (inflammation of the pancreas).
9.Pre-existing known coagulopathy.
10.Difficulty in swallowing tablets or capsules.
11.Use of any recreational drug or history of drug addiction.
12.Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 180 days prior to check-in.
13.Positive urine alcohol and urine drug of abuse tests during check-in.
14.Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
15.Lactating or nursing female subjects.
16.Female subjects using hormonal contraceptive (oral/implants).
17.History of allergy or hypersensitivity intolerance to asparaginase or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study.
18.History of difficulty in accessibility of veins in arms.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method