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

• Status: Completed
• Trial end date: 2018-09-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.