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

NCT05030025 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-03-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

COMBINATION_PRODUCT

abacavir, dolutegravir and lamivudine dispersible tablets

Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60 mg/5 mg/30 mg Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg)

COMBINATION_PRODUCT

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

Triumeq Dispersible Tablets 5 mg GSK1349572 \[Dolutegravir\]/ 60 mg Abacavir/ 30 mg Lamivudine Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg)

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Tracey Lawrence, Ph.D. · Mylan Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2021-08-29
Completion
2021-08-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030025 on ClinicalTrials.gov