bioequivalence study of Abacavir / Dolutegravir / Lamivudine (60 mg / 5 mg / 30 mg) Dispersible Tablets in Healthy adult male and female (not of childbearing potential) human volunteers under fed conditions.

Not Applicable

• Registration Number: CTRI/2021/04/033145
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 nonchild-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

3. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 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 Have normal ECG, Chest X-ray and vital signs.

7. Non-smoker and Non-alcoholic.

8. Subject able to communicate effectively and willing to provide informed consent.

9. Subject willing to adhere to protocol requirements as evidenced by informed consent approved by an Independent Ethics Committee (IEC).

Exclusion Criteria

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 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.

3. 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??.

I) Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification

II) Subject has creatinine clearance of <50 mL/min

4. Subject having Modified Patient Health Questionnaire (PHQ)-12 questionnaires >4.

5. Any history of bleeding disorders, peptic ulcer diseases, hemorrhoids, wounds/ulcers.

6. History or presence of drug abuse in the past one year.

7. Difficulty in swallowing tablets/capsules.

8. Any history of difficulty in donating blood.

9. Resting blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).

10. Pulse rate less than 60 beats / minute and more than 100 beats / minute.

11. 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.

12. Usage of any clinically significant medications during last 30 days preceding the first dosing.

13. Any clinically significant illness during 3 months before screening.

14. Participation in a drug research study/donation of blood within past 90 days.

15. ALT greaterthan equals to 1.5 ULN or total bilirubin ALT greaterthan equals to 1.5.

16. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of

Gilbert s syndrome or asymptomatic gallstones).Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.

17. Female subject demonstrating positive for pregnancy test (performed at the time of period-01 check-in).

18. 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