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Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions

NCT04723238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-15

No results posted yet for this study

Summary

This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.

Conditions

  • Bioequivalence

Interventions

DRUG

Duloxetine 60mg Test Drug Enteric Coated Granules

Investigational Medicinal Product

DRUG

Duloxetine 60mg Reference Product Enteric Coated Granules

Cymbalta (Eli Lilly)

Sponsors & Collaborators

  • Laboratorios Andromaco S.A.

    lead INDUSTRY

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
2021-01-23
Primary Completion
2021-02-09
Completion
2021-03-26

Countries

  • Chile

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 NCT04723238 on ClinicalTrials.gov