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A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants

NCT03627936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-17

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.

Conditions

  • Healthy Participants

Interventions

DRUG

Lorcaserin manufactured at Zofingen

Lorcaserin XR tablets manufactured at Zofingen.

DRUG

Lorcaserin manufactured at Kawashima

Lorcaserin XR tablets manufactured at Kawashima.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2018-09-02
Completion
2018-09-02
FDA Drug
Yes

Countries

  • United States

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 NCT03627936 on ClinicalTrials.gov