Bioequivalence Study of Dolutegravir dispersible tablets 10 mg (Fasting)
- Registration Number
- CTRI/2019/06/019834
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
i. Normal healthy adult male and female (not of childbearing potential) human subjects, age between 18 to 45 years (inclusive of both).
ii. Body mass index of greater than or eual to 18.5 kg/m2 and less than or eual to 24.9 kg/m2 and weight greater than or eual to 50.00 kg.
iii. Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing in Period-1.
iv. Subject whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance.
v. Have normal ECG, Chest X-ray and vital signs.
vi. Non-smoker and Non-alcoholic.
vii. Subject able to communicate effectively and willing to provide informed consent.
viii. Subject willing to adhere to protocol requirements as evidenced by informed consent approved by an Independent Ethics Committee (IEC).
ix. Subject is postmenopausal for at least 1 year.
or
is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
A subject will not be eligible for study participation if he/she meets any of the following criteria:
i. Any history of allergy or hypersensitivity to Dolutegravir or other related drugs.
ii. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis.
iii. The study drug is contraindicated for medical reasons.
iv. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders and â??Clinically significant abnormal values of laboratory parametersâ??.
v. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
vi. History or presence of drug abuse in the past one year.
vii. Difficulty in swallowing tablets/capsules.
viii. Any history of difficulty in donating blood.
ix. Had clinically significant abnormal values of laboratory parameters.
x. Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
xi. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
xii. Usage of any prescribed medication during last 14 days and for OTC medicinal products, herbal products during the last 07 days preceding the first dosing.
xiii. Any clinically significant illness during 3 months before screening.
xiv. Participation in a drug research study/donation of blood within past 90 days.
xv. Alanine transaminase (ALT) > 1.5 times upper normal limit.
xvi. Total bilirubin levels not in normal reference interval.
xvii. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
xviii. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
xix. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in).
Subject positive for breath alcohol test, urine screen for drugs of abuse [Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] at the time of each period check-in will be excluded from the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the oral bioequivalence study of Dolutegravir dispersible tablets 10 mg of Mylan Laboratories Limited, Hyderabad with GSK1349572 (Dolutegravir) 5mg/DISP TAB Site of manufacture: GSK GMS ware United Kingdom, in normal healthy adult male and female (not of childbearing potential) human subjects under fasting conditions.Timepoint: as it is a bio-equivalence study we will evaluate safety of the volunteers after clinical phase completion and bio-equivalence after Bio-Analytical phase
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of the subjects.Timepoint: 45 days clinical schedule