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Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets

NCT05968612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-12-26

No results posted yet for this study

Summary

The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) in the fed state, and food-effect bioavailability of Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) in the fasted and fed state in healthy, non-smoking, male and non-pregnant female volunteers, 18 to 55 years of age, inclusive.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet

Film-coated tablet administered orally.

DRUG

Lumacaftor 200 mg Film-Coated Tablet Formulation

Film-coated tablet administered orally.

Sponsors & Collaborators

  • Qanatpharma Canada LTD

    lead INDUSTRY

Principal Investigators

  • Isabella Szeto, MD, CCFP · BioPharma Service Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2023-12-18
Completion
2023-12-18

Countries

  • Canada

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 NCT05968612 on ClinicalTrials.gov