None listed
Conditions
Interventions
Intervention1: Paracetamol Injection (500 mg/2 mL) manufactured by: Troikaa Pharmaceuticals Ltd., India: A single dose of 2 mL injection would be administered byintramuscular route
Control Interventio
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Healthy, Indian, male, fair human volunteers aged from 18 to 45 years. ii. Body mass index should be within 18.0-24.75 kg/m2. iii. Hip circumference should be within 85 - 110 cms. iv. Voluntarily willing and capable to give written and signed informed consent prior to participation in the study, according to the form attached in appendix - 1. v. Availability for the entire study period and willingness to adhere to the protocol and study requirements. vi. Voluntarily willing to undergo pre- and post-study physical examinations and laboratory investigations. vii. Having no significant disease or abnormal laboratory values on laboratory examination with no clinical relevance, medical history or physical examination during screening. viii. 12-lead supine EeG in resting position and vital signs within normal limits or showing minor aberrations, which the investigator does not consider of clinical relevance. ix. Normal chest X-ray findings or findings that have no clinical correlation. x. Non-smokers xi. Having not consumed alcohol at least 48 hrs. prior to the IMP administration justified by negative breath-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study. xii. Negative unne test for drug of abuse [amphetamine, barbiturate,tetrahydrocannabinoids, morphine, cocaine, benzodiazepine]. xiii. Having not consumed grapefruit or orange juice/products within 48 hrs. of the IMP administration.
Exclusion criteria
Exclusion criteria: i. History of allergy or sensitivity to paracetamol or any other drug, which, in the opinion of the investigator, would compromise the safety of the subject or the study. ii. History of epilepsy, previous history of severe respiratory disorders such as chronic obstructive airways disease, tuberculosis, pleurisy or pneumonia within last 1 year. iii. History of diseases of liver or hepatic impairment within last one [1] year. iv. Elevated serum transaminases [SGOTI SGPT] or alkaline phosphatase. v. Serious, uncontrolled disease [including serious psychological disorders] likely to interfere with the study andlor likely to cause death within the study duration. vi. Participation in another clinical study or a blood donation program or having had blood loss of more than 350 mL during the last 90 days. vii. Renal insufficiency [serum creatinine more than twofold of >3 mg/dL]. viii. Seropositive for VDRL, HIV [lor II] or hepatitis B or C infection. ix. Any clinically significant abnormality [to be determined by the investigator] following review of screening laboratory data and full physical examination. x. Vital sign abnormalities [systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg or heart rate 120 bpm] at the preadmission physical examination. xi. 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. xii. Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug. xiii. Having taken OTC or prescribed medications, including any enzyme-modifying drugs or any systemic medication, within the last 30 days prior to the study. xiv. Having a history of alcohol or substance abuse within the last 5 years. xv. Habit of chewing or inhaling nicotine-containing products [e.g. tobacco] currently or within last six months prior to the study. xvi. Abnormal INR combined with clinical manifestation. xvii. Consumption of xanthine-containing derivatives [coffee, tea, cola drinks, chocolate] within 24 hrs. before IMP administration and grapefruit or orange juice for at least 48 hrs. prior to IMP administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain at the time of IMP administration as expressed using Wong-Baker Faces Pain Rating Scale. 2. Pain on VAS scale at each time point 3. Injection site reaction at each time point 4. Number of drug-related [definite or probable or possible] adverse events 5. Clinical chemistry profile at the end of the study [PSSA]Timepoint: Subjects facial expression would be recorded with the help of WongBaker Faces Pain rating scale [No hurt to hurts worst]. Assessment of pain: 0.00,0.25,0.50,0.75,1.00,1.50,2.00,3.00,5.00,9.00 and 13.00 and at the time of discharge. Vital examination: at the time of admission, 0.00,1.00,2.00,3.00, 5.00,9.00 and 13.00 and at the time of discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCo-inf, AUCo-t, Cmax, tmax, Kel, t1/2Timepoint: The concentration of paracetamol will be determined at following time points: 0.00,0.17,0.33,0.50,0.67,0.83,1.00,1.25,1.50,1.75,2.00,2.50,3.00,3.50,4.00,5.00,7.00,10.00,12.00,16.00 and 24.00 hrs. 5 mL blood would be collected in plain vacuum tube for investigating creatine phosphokinase [CPK] at 0.00 [baseline] hr. and at 6.00, 12.00 and 24.00 hrs. post-dose as part of safety assessment. | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Troikaa Pharmaceuticals Limited
Outcome results
None listed