Bioequivalence study of generic drug of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) with comparision to the marketed drug under fasting conditions
- Registration Number
- CTRI/2022/02/040130
- Lead Sponsor
- APL Research Centre Aurobindo Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy, adult, male subjects within the age range of 18 to 45 years (inclusive of both).
2.A body mass index within the range of 18.50-29.99 Kg/m2 (inclusive of both).
3.Participation is truly voluntarily.
4.Given written informed consent to participate in the study.
5.Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and RPR (i.e. Rapid Plasma Reagin).
6.Absence of significant diseases and abnormalities in medical history, systemic and physical examination during the screening.
7.Absence of clinically significant abnormal laboratory values on laboratory evaluation (any laboratory values which are beyond the normal ranges, have been evaluated with appropriate justification by the investigator/physician) during screening (refer Appendix-V).
8.A normal 12-lead ECG.
9.The subject is negative for the HLA-B X 5701 allele.
10.The subject is negative result for the Hepatitis B core antibody (Anti-HBc (total or immunoglobulin G (IgG))) and HBV DNA (Qualitative) performed on the day of ICF.
11.Normal in assessment of Columbia Suicidality Severity Rating Scale (C-SSRS) (refer Appendix-XVI) performed during check-in of each period.
12.Normal values in the assessment of depression using depression scale (refer Appendix-XV) during check-in of each period.
13.Normal levels of serum amylase test, serum creatine phosphokinase (CPK) test and serum triglycerides test performed during check-in of period-I.
14.Having Creatinine clearance (CKD-EPI) test values greater than 90 mL/min performed during period-I check-in.
15.A normal chest X-ray (PA view) (done within past 06 months).
16.Able to comply with requirement of the entire protocol.
17.Male subject should be agreed to use contraception during the study including washout period. Approved birth control methods (barrier forms) during this period are:
•Male latex condom with or without spermicide.
•Condom with diaphragm.
•Have undergone vasectomy (vasectomy must have been done more than 06 months prior to first dosing).
18.Subjects who are able to read the medication guide (Appendix-XIV) and Informed Consent Document.
1.Institutionalized volunteers.
2.History or evidence of known hypersensitivity to Dolutegravir, Abacavir and Lamivudine or any component of the formulations.
3.History or evidence of moderate to severe renal impairment or moderate to severe hepatic impairment.
4.History or evidence of depression, suicidal ideation or behaviour.
5.History or evidence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilberts syndrome or asymptomatic gallstones).
6.History or evidence of myocardial infarction (MI).
7.History or evidence of lactic acidosis and severe hepatomegaly with steatosis.
8.History or evidence of general malaise, fatigue, muscle or joint aches, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.
9.History or evidence of Alanine aminotransferase (ALT) greater than 1.5 x ULN and/or total bilirubin greater than 1.5 x ULN at baseline (isolated bilirubin greater than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
10.History or evidence of concomitant use of Dofetilide (or pilsicainide), Etravirine, Trimethoprim, Efavirenz, Nevirapine, Fosamprenavir or ritonavir and Tipranavir or ritonavir, Dalfampridine, Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, St. Johns wort (Hypericum perforatum), medications containing polyvalent cations (Mg or Al) Cation containing antacids or laxatives, Sucralfate buffered medications, oral calcium and iron supplements, including multivitamins containing calcium or iron, Metformin, Rifampin, Methadone, Sorbitol and Riociguat.
11.Positive test result for hepatitis B core antibody (Anti-HBc (total or immunoglobulin G (IgG)) and HBV DNA (Qualitative) performed on the day of ICF.
12.Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) performed during screening.
13.Positive test result for HIV 1 and HIV Type 2 (HIV 2) antigen or antibody immune assay performed during screening.
14.Subjects who are having clinical significant laboratory values in liver function test (LFT) performed during check in of period II.
15.Blood pressure: Systolic greater than 140 mm Hg and less than 110 mm Hg
16.Diastolic less than 70 mm Hg and greater than 90 mm Hg
17.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, metabolic disorders, nutritional disorders and or allergic rash.
18.Any family history of neurological disorder.
19.Habit of consuming high caffeine (more than 5 cups of coffee or tea per day) or tobacco (more than 9 cigarettes or beedies or cigars per day).
20.History of alcohol consumption for more than two units/day (1 unit equals to 30 mL of spirit or 1 pint of beer).
21.History of difficulty with donating blood or difficulty in accessibility of veins.
22.Donation of blood (one unit or 350 mL) within 90 days prior to study check in.
23.History of addiction to any recreational drug or drug dependence.
24.Participation in any clinical study within the past 90 days.
25.An unusual or abnormal diet, for whatever reason for at le
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method