None listed
Conditions
Interventions
Intervention1: Dolutegravir Sodium Dispersible Tablet 10 mg: To determine bioequivalence
Control Intervention1: Dolutegravir Dispersible Tablet 5 mg: To determine bioequivalence
Sponsors
Macleods Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The subjects will be included based on the following criteria: 1.Healthy 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 clinically significant 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.
Exclusion criteria
Exclusion criteria: The subjects will be excluded based on the following criteria: 1.Personal history of allergy or hypersensitivity to Dolutegravir or allied drugs or excipients. 2.Any major illness in the past 90 days or any clinically significant ongoing chronic medical illness 3.Presence of any clinically significant abnormal laboratory values during screening 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 and history of head trauma. 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 or having consumed alcohol within 48 hours prior to dosing. 9.Consumption of products containing xanthine derivatives or tobacco products within 48 hours prior to dosing. 10.Consumption of grapefruit or grapefruit containing products or any cruciferous vegetables or char-broiled meat prior 7 days 11.Consumption of products containing Ca/Fe/Mg within 48 hours prior to dosing. 12.Use of any recreational drug or a history of drug addiction. 13.Participation in any clinical trial within the past 90 days. 14.History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm. 15.Donation of blood within 90 days prior to receiving the first dose of study medication. 16.Consumption of any other prescription drug or over the counter (OTC) drugs and receiving dofetilide within two weeks prior to receiving the first dose of study medication. 17.An unusual diet for whatever reason e.g. low sodium diet. 18.Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 48 hours prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the comparative oral bioavailability of Dolutegravir Sodium Dispersible Tablet 10 mg (Macleods Pharmaceuticals Ltd., India) with two tablets of Dolutegravir Dispersible Tablet 5 mg (ViiV Healthcare, UK) in healthy, adult, male subjects under fed condition.Timepoint: To evaluate the comparative oral bioavailability of Dolutegravir Sodium Dispersible Tablet 10 mg (Macleods Pharmaceuticals Ltd., India) with two tablets of Dolutegravir Dispersible Tablet 5 mg (ViiV Healthcare, UK) in healthy, adult, male subjects under fed condition. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of single oral dose of Dolutegravir Sodium Dispersible Tablet 10 mg when administered in healthy, adult, male subjects under fed condition.Timepoint: Throughout the study period and 5 drug half life | — |
Countries
India
Contacts
Public ContactDr Pratip Sen
Macleods Pharmaceuticals Ltd.
Outcome results
None listed