A comparative pharmacokinetic study to evaluate safety and tolerability of Paracetamol Intravenous Injection 1000 mg/4 m
- Registration Number
- CTRI/2021/09/036276
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy adult human subjects, aged between 18 to 45 years (both inclusive) and weight >50 Kg
2.Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2
3. If subject is a female and is of
child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
OR
Surgically sterile, bilateral tubal ligation should be documented.
4.Subjects able and willing to comply with the protocol requirements.
5.Subjects willing to voluntarily provide written informed consent.
6.Subjects willing to undergo pre- and post-study physical examinations and laboratory investigations.
7.Subjects willing to adhere to the protocol and the following study requirements:
Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and remaining based on history) until the last sample collection.
Should not consume grapefruit or its products at least 7 days prior to each dosing (i.e. during in-house monitoring and remaining based on history) and until the last sample collection
8.Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, 12-lead ECG, chest X-Ray or vital signs.
9.Subjects who are non-alcoholic, non-smokers or those who are ex-smokers and have less than a 10 pack-year history of smoking and have not consumed tobacco or tobacco containing products for at least 12 months prior to screening and who agree to abstain from the same until the last blood sample collection of the last period.
10.For male Subjects:
Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects should also not donate sperm during study period
1.Subjects incapable of understanding the informed consent process.
2.Pregnant female subjects with a positive pregnancy test at screening or positive serum β-HCG test or lactating females.
3.Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria, at least 14 days prior to the first dose of study medication. Use of hormonal contraceptives either oral or implants will not be acceptable
4.Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study.
5.Subjects with active history of any psychiatric disorders, which are likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
6.Subjects with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
7.Subjects with signs of dehydration or malnutrition
8.Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within 30 days prior to the start of the clinical period and during the study period.
9.Subjects with a known history of drug hypersensitivity to Paracetamol or to propacetamol hydrochloride (prodrug of paracetamol) or any excipients of the formulation.
10.Subjects with a history of alcohol abuse and/or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) or are found with current alcohol abuse based on Urine Alcohol/alcohol breath test.
11.Subjects diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
12.Subjects with clinically significant abnormal haematological values [haemoglobin (Hb), total white blood cells count (WBC), total red blood cells count (RBC), differential WBC count, platelet count and hematocrit, peripheral smear (for female only)].
13.Subjects with clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting), and serum cholesterol.
14.Subjects with clinically significant abnormal urine analysis, defined as the presence of RBC ( >5/HPF), pus cells ( >5/HPF), epithelial cells ( >5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive) (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
15.Subjects with a clinically significant past history or current medical condition of:
Pulmonary disorders (COPD and asthma)
Bleeding disorders
Cardiovascular disorders (especially heart blocks, myocardial infarction, congestive heart failure and uncontrolled hypertension)
Neurological disorders (especially epileptic seizures)
GIT disorders (gastrointestinal bleeding, gastric/peptic ulcer)
Renal insufficiency and/or hepatic disorders or severe hepatocellular insufficiency
Coagulation disorders
Endocrine disorders (especially diabetes mellitus)
16.Subjects who participated in any other clinical inv
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Plasma concentrations of Paracetamol will be measured <br/ ><br>using validated LC-MS/MS bioanalytical method <br/ ><br>Primary variables <br/ ><br>Cmax <br/ ><br>AUC0-t <br/ ><br>AUC0-infTimepoint: 1 hour prior to drug administration, at baseline (0.00 hour) and subsequent samples will be collected at 0.034, 0.085, 0.17, 0.25, 0.50, 0.75, 1.00, 2.00, 4.00, 6.00, 10.00, 12.00, 16.00,24.00 hours
- Secondary Outcome Measures
Name Time Method Tmax <br/ ><br>AUC_%Extrap_obs <br/ ><br>t1/2 <br/ ><br>KelTimepoint: 1 hour prior to drug administration, at baseline (0.00 hour) and subsequent samples will be collected at 0.034, 0.085, 0.17, 0.25, 0.50, 0.75, 1.00, 2.00, 4.00, 6.00, 10.00, 12.00, 16.00,24.00 hours