Bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) with comparision to the marketed product under fasting conditions.
- Registration Number
- CTRI/2021/04/033077
- Lead Sponsor
- APL Research Centre Aurobindo Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
1.Healthy, adult, human 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 and 2, hepatitis B and C virus and RPR.
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.Normal values in the assessment of depression using depression scale (refer Appendix-XV) during check-in of each period.
10.Normal values of Creatinine clearance (CrCl) test during period I check-in.
11.Normal levels of serum amylase test, serum creatine phosphokinase (CPK) test and serum triglycerides test during check-in of period I.
12.The subject is negative for the HLA-B X 5701 allele test.
13.A normal chest X-ray (PA view) (done within past 06 months).
14.Compliance with requirement of the entire protocol.
15.Individuals of childbearing potential may be eligible to enter and participate in the study if they are of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and equal to or older than 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy
16.Male subject should be agreed to use an approved form of birth control from period-I dosing till 01 month after the last dose of the study medication as a birth control restriction. Approved birth control methods (barrier forms) during this period are:
a.Male latex condom with or without spermicide.
b.Condom with diaphragm
c.Have undergone vasectomy (vasectomy must have been done more than 06 months prior to first dosing)
17.Subjects who are able to read the medication guide (Appendix-XIII) 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 immune reconstitution syndrome, Mycobacterium avium infection, cytomegalovirus, pneumocystis jirovecii pneumonia or tuberculosis, Graves disease and polymyositis
6.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)
7.History or evidence of myocardial infarction
8.History or evidence of lactic acidosis and severe hepatomegaly with steatosis
9.History or evidence of pancreatitis
10.History or evidence of ALT greater than 1.5 ULN and or total bilirubin ALT greater than 1.5 at baseline
11. History or evidence of concomitant use of Dofetilide (or pilsicainide), Etravirine, Trimethoprim, Efavirenz, Nevirapine, Fosamprenavir/ ritonavir and Tipranavir/ ritonavir, Dalfampridine, Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, St. Johns wort (Hypericum perforatum), medications containing polyvalent cations (example: 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 and Sorbitol
12. Blood pressure: Systolic greater than 140 mm Hg and less than 110 mm Hg, Diastolic less than 70 mm Hg and greater than 90 mm Hg
13. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, metabolic disorders, nutritional disorders and or allergic rash
14.Family history of neurological disorder
15.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day)
16.History of alcohol consumption for more than two units per day (1 unit equals to 30 mL of spirit or 1 pint of beer)
17.History of difficulty with donating blood or difficulty in accessibility of veins
18.Donation of blood (one unit or 350 mL) within 90 days prior to study check-in
19.History of addiction to any recreational drug or drug dependence
20.Participation in any clinical study within the past 90 days
21.An unusual or abnormal diet, for whatever reason for at least 48.00 hours prior to check-in of each period, example: fasting due to religious reasons
22.Use of any prescription drugs or over-the-counter drugs (example: cold preparations, antacid preparations, vitamins or natural products etc) within 14 days prior to check-in of period-I and unwilling to refrain from the same till the entire duration of the study
23.Consumed food or beverages containing alcohol or xanthine products (chocolate, tea, coffee, cola or energy drinks), cigarettes or tobacco products for at least 48.00 hours prior to check-in of each period.
24.Consumed grapefruit or grapefruit like citrus fruits (mosambi/ sweet lime) or juice for at least 48.00 hours prior to check-in of each period <br/
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the bioequivalence between Test product (T): Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) of Aurobindo Pharma Limited, India with that of Reference product (R): Dolutegravir (GSK1349572)/Abacavir/Lamivudine Dispersible Tablets 5 mg/60 mg/30 mg (1 Ã? 5 Tablets) of ViiV Healthcare, USA in 14 healthy, adult, human subjects under fasting conditionsTimepoint: Predose (00.00 hrs) and post dose samples at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 08.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours in each period
- Secondary Outcome Measures
Name Time Method To monitor the subjects safety and tolerability of single-dose of investigational products (IPs). <br/ ><br>Adverse events and clinically significant deviations from laboratory tests, physical examinations and vital signs will be reported for the evaluation of safety. <br/ ><br>Timepoint: Throughout the study duration