Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

Mylan

Status and phase: Completed; Early Phase 1

Conditions: HIV-1-infection

Treatments: Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine; Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05030025

ABDL-TBP-1001

Details and patient eligibility

About

The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.

Full description

This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg GSK1349572 [dolutegravir]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under fasting and fed conditions.

Adverse events will be monitored to ensure the safety and well-being of the healthy volunteers.

Enrollment: 43 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

• 18 to 55 years old.
• Males and/or females not of child-bearing potential.
• Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 19.0 kg/m2.
• Adequate venous access in both arms.
• Only non-tobacco/non-nicotine subjects.
• Able to understand and sign the written Informed Consent Form.
• Willing to follow the protocol requirements and comply with protocol restrictions.
• All subjects should be judged by the Principal Investigator or Medical Sub- Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication.

Exclusion Criteria - Subject candidates must not be enrolled in the study if subject meet any of the following criteria:

• Institutionalized subjects.
• Social Habits, Medications and Diseases will be evaluated.
• Use of certain foods and processed candies, gums food/drinks that contain sugar alcohols.
• Liver function tests (ALT, AST and total bilirubin).
• Subjects who are positive for the HLA-B*5701 allele.
• Subjects having Modified Patient Health Questionnaire (PHQ)-12 questionnaire score > 4.
• Subject has a creatinine clearance < 90 mL/min, as determined by the Cockroft-Gault equation.
• Any reason which, in the opinion of the Principal Investigator or Medical Sub- Investigator, would prevent the subject from safely participating in the study.
• Intolerance to venipuncture.
• Donation or loss of blood or plasma.
• Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.
• Allergy or hypersensitivity to abacavir, dolutegravir, lamivudine, other related products, or any inactive ingredients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Group 1

Experimental group

Description:

single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fasting conditions.

Treatment:

Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets

Group 2

Experimental group

Description:

single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fed conditions.

Treatment:

Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets