Bioequivalence study of Abacavir, Dolutegravir and Lamivudine tablets for oral suspension 60mg/5mg/30mg in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions
- Registration Number
- CTRI/2022/06/043078
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
1. Normal healthy adult male and female (not of childbearing potential) human subjects, age
between 18 to 45 years (inclusive of both).
2. A female may be eligible to enter and participate in the study if she is of non-childbearing
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
documented tubal ligation, hysteroctomy or bilateral oophorectomy.
3. Body mass index of >= 18.5 kg/m2 and <= 24.9 kg/m2 and weight >= 50.00 kg.
4. Healthy according to the laboratory results and physical examination, performed within 21
days prior to the commencement of the dosing in Period-1.
5. 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.
6. HLA-B 5701 allele negative subjects.
7. Have normal ECG, Chest X-ray and vital signs.
8. Non-smoker and Non-alcoholic.
9. Subject able to communicate effectively and willing to provide informed consent.
10. Subject willing to adhere to protocol requirements as evidenced by informed consent
approved by an Independent Ethics Committee (IEC).
A subject will not be eligible for study participation if he/she meets any of the following
criteria:
1. Any history of allergy or hypersensitivity to Abacavir / Dolutegravir / Lamivudine or other related drugs.
2.Positive test result for or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis.
3. Positive hepatitis B surface antigen (HBs Ag) and hepatitis C virus antibody (HCV Ab) test results at screening or within 03 months prior to starting the study intervention are excluded
from the study.
4. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or disorders
and Clinically significant abnormal values of laboratory parameters.
a. Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification.
b. Subject has creatinine clearance of <60 mL/min
5. Subject having Modified Patient Health Questionnaire (PHQ)-12 questionnaires >4.
6. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ ulcers.
7. History or presence of drug abuse in the past one year.
8. Difficulty in swallowing tablets/capsules.
9. Any history of difficulty in donating blood.
10. Resting Blood pressure is < 110/70 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
11. Resting Pulse rate less than 60 beats / minute and more than 100 beats / minute.
12. 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.
13. Usage of any clinically significant medications last 30 days preceding the first dosing.
14. Any clinically significant illness during 3 months before screening.
15.Participation in a drug research study/donation of blood within past 90 days.
16. ALT > 1.5 xULN or total bilirubin > 1.5 xULN.
17. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones).
18. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
19. Breastfeeding
20. Clinically significant history of psychiatric disease.
21. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in).
Subject positive for alcohol test (by using urine/ blood), urine screen for drugs of abuse
[Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] and pregnancy test (for female subjects only) 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
- Secondary Outcome Measures
Name Time Method