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Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition

NCT02291367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-11-14

No results posted yet for this study

Summary

This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 60 mg) in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects

Conditions

  • Healthy

Interventions

DRUG

Duloxetine

Duloxetine Delayed-Release Capsules 60 mg

DRUG

Cymbalta®

60 mg capsule of Eli Lilly and Company

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mayur Soni, MBBS · BA Research India Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • India

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 NCT02291367 on ClinicalTrials.gov