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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID

NCT03627936

Run by

Eisai Inc.

People needed

40

Starts

2018-08-07

Expected to finish

2018-09-02

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Non-smoking, healthy participants at the time of informed consent.
• Body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^2) (inclusive) at Screening.

You may not qualify if…

• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing.
• Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
• History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug, cotinine, or alcohol test at Screening or Baseline.
• Participants who contravene the restrictions on concomitant medications, food and beverages.
• Currently enrolled in another clinical study or used any investigational drug or device within 4 weeks preceding informed consent.
• Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.

Where it is running

• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.