To determine the safety, tolerability, uptake and breakdown of single and multiple doses of AS012 in healthy subjects.
- Registration Number
- CTRI/2019/08/020753
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd SPI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 167
1. Healthy male and female subjects between 18-45 years (both inclusive) of age at screening,
having weight at least 50kg and Body Mass Index (BMI) within 18.50 â?? 30.00 (kg/m2) (both
inclusive).
2. Voluntarily given informed consent to participate in this study.
1. Female subjects who are pregnant or lactating.
2. History of hypersensitivity to test articles or related substances.
3. History of viral, systemic, fungal, bacterial or protozoal infection (flu-like symptoms (cough, fever) within 4 weeks before Screening.
4. Evidence of organ dysfunction or any clinically significant deviation in clinical examination or laboratory determinations.
5. Presence of medical illness including, but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, psychiatric or hematological disease, diabetes or glaucoma.
6. Inability to communicate well (i.e. language problem, poor mental development, psychiatric
illness or poor cerebral function) that may impair the ability to provide written informed
consent.
7. Use of any medication within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug and anticipated need of use during the study.
8. Subjects who have participated in another clinical study within 90 days prior to dosing in Period-1 or blood donation of 350 ml or more within 90 days prior to dosing in period 1.
9. Subjects with a current or past history of drug or substance and/alcohol abuse.
10. Subject who have shown positive result in breath alcohol and/or urine drug screening test at check in of any period.
11. Current smoking or use of tobacco products or substitutes.
12. Subject determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results (e.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy)
13. Subjects who refuse to refrain from strenuous physical work or exercise from Screening until the end of study visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1 â?? Single Ascending Dose: <br/ ><br>Safety and tolerability parameters including adverse events, Clinical examination, clinical laboratory values, vital signs, and ECG after single dose administration. <br/ ><br> <br/ ><br>Part 2 Multiple Ascending Dose: <br/ ><br>Safety and tolerability parameters including adverse events, Clinical examination, clinical laboratory values, vital signs, and ECG after multiple dose administration.Timepoint: Part 1 â?? Single Ascending Dose: up to 72 hours and on day 8±1. <br/ ><br> <br/ ><br>Part 2 Multiple Ascending Dose: up to 15 days and on day 22±1
- Secondary Outcome Measures
Name Time Method Part 1-Single Ascending Dose- <br/ ><br>Pharmacokinetic parameters of components of AS012, after single dose administration. <br/ ><br>Dose-concentration relationship of components of AS012 after single dose administration. <br/ ><br> <br/ ><br>Part 2-Multiple Ascending Dose- <br/ ><br>Pharmacokinetic parameters after day 1 first dose and after day 14-morning dose of AS012, after multiple dose administration. <br/ ><br>Dose-concentration relationship of the components of AS012, after multiple dose administration.Timepoint: Part 1 â?? Single Ascending Dose: up to 72 hours and on day 8±1. <br/ ><br> <br/ ><br>Part 2 Multiple Ascending Dose: up to 15 days and on day 22±1