None listed
Conditions
Interventions
Intervention1: Xykaa Extend 1000 (Paracetamol 1000 mg extend release) tabs manufactured by: Troikaa Pharmaceuticals Ltd., India: One tablet of Xykaa Extend 1000 will be orally administered twice a day
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Healthy human adult literate subjects between 18-45 years of age (inclusive), having a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive). ii. Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to study start. iii. Subjects whose screening laboratory values, vital signs, ECG and chest X- ray are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance. iv. Nonsmokers or ex-smokers (nonsmokers for at least 3 months). v. Subjects do not consume any other form of tobacco products. vi. Informed consent given in written form according to section 11.3 of the protocol. vii. Female Subjects • of child bearing potential 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. • postmenopausal for at least 1 year. • surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion criteria
Exclusion criteria: 1. Known history of i. Cardiovascular, pulmonary, hepatic or liver impairment, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. ii. Elevated serum transaminases [SGOT/ SGPT] or alkaline phosphatase iii. Asthma, urticaria or other allergic type reactions after taking any medication. iv. Hypersensitivity to Paracetamol and any other similar class of drugs or any of its excipients. 2. History or presence of i. Significant alcohol dependence, alcohol abuse or drug abuse within past one year. ii. Moderate to heavy smoking (more than 10 cigarettes/day) iii. Consumption of tobacco products more than 4 packets/day. iv. Difficulty in swallowing tablet/capsule. v. Clinical illness within 4 weeks before the start of the study 3. i. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the preceding 90 days prior to the start of the study. ii. Subject has donated blood in the preceding 90 days prior to the start of the study. 4. Subject who have Positive Urine drug screening, Alcohol breath analysis, HIV, VDRL/RPR, Hepatitis B & C tests. 5. Subjects who have: i. Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg ii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator. iii. Pulse rate below 60 beats/minute or above 100 beats/minute. 6. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Employing the estimated concentration vs. time profiles of Paracetamol, the following pharmacokinetic parameters will be calculated: On Days 01, 02 and 04: Cpd On Day 04: Primary Pharmacokinetic Parameters: Ctau(ss), Cmax(ss), AUCt and AUCtau(ss) Secondary Pharmacokinetic Parameters: Cmin(ss), Cavg(ss), Cpd, Fluctuation(%PTF), Swing, Tmax(ss), t1/2(ss), and Kel(ss), T more than 4 ug/mLTimepoint: Predose samples will be collected within 5 minutes prior to morning dosing time on day 01, 03 and 04 Timepoints for Test Pdt: Post morning dose on day 04 at 0.250, 0.500, 0.750,1.000, 1.500, 2.000,3.000, 4.000, 6.000, 8.000, 10.000, 12.000 and 24.000 h. Timepoints for Ref Pdt: Post morning dose on day 04 at 0.250, 0.500, 0.750,1.000, 1.500, 2.000, 4.000, 6.000, 6.250, 6.500,6.750, 7.000, 7.500, 8.000, 10.000, 12.000 and 24.000 h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Pharmacokinetic Parameters: Cmin(ss), Cavg(ss), Cpd, Fluctuation(%PTF), Swing, Tmax(ss), t1/2(ss), and Kel(ss), T more than 4 ug/mLTimepoint: Predose samples will be collected within 5 minutes prior to morning dosing time on day 01, 03 and 04. Timepoints for Test Pdt: Post morning dose on day 04 at 0.250, 0.500, 0.750,1.000, 1.500, 2.000,3.000, 4.000, 6.000, 8.000, 10.000, 12.000 and 24.000 h. Timepoints for Ref Pdt: Post morning dose on day 04 at 0.250, 0.500, 0.750,1.000, 1.500, 2.000, 4.000, 6.000, 6.250, 6.500,6.750, 7.000, 7.500, 8.000, 10.000, 12.000 and 24.000 h. | — |
Countries
India
Contacts
Public ContactDr Jyoti Paliwal
Troikaa Pharmaceuticals Limited
Outcome results
None listed