A study to evaluate the blood levels of Dolutegravir Dispersible Tablet 10mg (test) compared to the Reference 02 tablets of Dolutegravir Dispersible Tablet 5mg in healthy subjects (fed).
- Registration Number
- CTRI/2020/06/025532
- Lead Sponsor
- Macleods Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy human male volunteers within the age range of 18 to 45 years.
2.Presently non-tobacco users (smokers and chewers).
3.Willingness to provide written informed consent to participate in the study.
4.Body-mass index (BMI) between 18.50 kg/m2 and 29.99 kg/m2 (both inclusive) with body weight not less than 50 kg.
5.Absence of significant disease or abnormal laboratory values or laboratory evaluation, medical history or physical examination during the screening.
6.Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
7.Have a normal chest X-ray PA view or one with abnormality considered to be clinically insignificant.
8.Comprehension of the nature and purpose of the study and compliance with the requirement of the distributed ICF.
1. Personal history of allergy or hypersensitivity to Dolutegravir or allied drugs or excipients (D-Mannitol,Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Silicified Microcrystalline Cellulose,
Crospovidone, Calcium Sulfate Dihydrate, Sucralose, Strawberry Cream Flavour, Sodium Stearyl Fumarate, White film coat (Contains: Hypromellose, Polyethylene Glycol and Titanium Dioxide)].
2.Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness e.g. Congestive Cardiac Failure, Hepatitis, Hypotensive episodes, Hyperglycemia etc.
3.Presence of any abnormal laboratory values during screening e.g. abnormality of liver function test, renal function test etc.
3.1Alanine transaminase (ALT) >1.5x upper limit of normal (ULN)
3.2Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
3.3Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones)
4.Severe cardiac, renal or liver impairment, gastro-intestinal disease or other conditions, any other organ or system impairment.
5.History of seizures, epilepsy or any kind of Neurological disorders.
6.Past history of Anaphylaxis or Angioedema.
7.Presence of disease markers of HIV or Hepatitis B or Hepatitis C virus.
8.History of chronic consumption of any kind of alcoholic beverages for more than 2 years or having consumed alcohol within 48 hours prior to dosing.
9.Consumption of products containing xanthine derivatives (chocolates, tea, coffee or cola drinks) or tobacco products within 48 hours prior to dosing.
10.Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables (eg. broccoli, brussels sprouts, etc.) or char-broiled meat prior 7 days of investigational product administration.
11.Use of any recreational drug or a history of drug addiction.
12.Participation in any clinical trial within the past 90 days.
13.History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
14.Donation of blood (one unit or 350 mL) within 90 days prior to receiving the first dose of study medication.
15.Consumption of any other prescription drug or over the counter (OTC) drugs (including vitamins and medicinal products from natural origin) within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks and throughout subjects participation in the study.
16.Consumption of products (medicines or supplements) containing Ca/Fe/Mg within 48 hours prior to dosing.
17.An unusual diet for whatever reason e.g. low sodium diet, for two weeks prior to receiving any medication and throughout subjects participation in the study.
18.Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 48 hours prior to the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the comparative oral bioavailability <br/ ><br>of single dose of Dolutegravir Sodium Dispersible Tablet 10 mg <br/ ><br>(Macleods Pharmaceuticals Ltd., India) with two tablets of <br/ ><br>Dolutegravir Dispersible Tablet 5 mg Dolutegravir 5mg dispersible <br/ ><br>tablets manufactured by GlaxoSmithKline, UK on behalf of ViiV <br/ ><br>Healthcare, UK in healthy, adult, human male subjects under fed <br/ ><br>condition.Timepoint: Blood samples will be collected as per sampling schedule for period of 72 hrs per period. After completing study bioanalytical evaluation will be conducted. After completion oral bioavailability will be evaluated.
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of a single oral dose of Dolutegravir Sodium Dispersible Tablet 1 O mg and two tablets of Dolutegravir 5mg dispersible tablets when administered in healthy, <br/ ><br>adult, human male subjects under fed condition.Timepoint: The safety and tolerability will be monitored throughout the study period i.e. for 12 days. After completion of the study, it will be further monitored for 4 days.