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Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions

NCT04386876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-31

No results posted yet for this study

Summary

A single dose of Reference product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination and a single dose of Test product containing 200 mg lopinavir and 50 mg ritonavir fixed dose combination or vice versa; administered with 240 mL of water at room temperature, in each period under fasting conditions.

Conditions

  • Bioequivalence

Interventions

DRUG

Lopinavir/Ritonavir 200 mg/50 mg Film Tablet

Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).

DRUG

Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet

Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH \& Co.-Germany)

Sponsors & Collaborators

  • Novagenix Bioanalytical Drug R&D Center

    collaborator NETWORK

  • Farmagen Ar-Ge Biyot. Ltd. Sti

    collaborator NETWORK

  • World Medicine ILAC SAN. ve TIC. A.S.

    lead INDUSTRY

Principal Investigators

  • Muradiye Nacak, MD,PhD · Farmagen Ar-Ge Biyot. Ltd. Sti

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-05-22
Completion
2020-06-11

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT04386876 on ClinicalTrials.gov