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

Healthy Participants Clinical Trial

Official title:

A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen Under Fasted Conditions in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627936
• Other study ID #: APD356-A001-040
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2018
• Est. completion date: September 2, 2018

Study information

• Verified date: August 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lorcaserin manufactured at Zofingen
Lorcaserin XR tablets manufactured at Zofingen.
• Lorcaserin manufactured at Kawashima
Lorcaserin XR tablets manufactured at Kawashima.

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Primary	Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Primary	Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Primary	Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, and 72 hours postdose in each treatment period; treatment period length = 4 days
Primary	Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Primary	Terminal elimination phase half-life (t½) of Lorcaserin		predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days
Secondary	Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)		Baseline up to 28 days after last dose of study drug (Day 35)
Secondary	Number of Participants With Markedly Abnormal Laboratory Values		Baseline up to Day 11
Secondary	Number of Participants With Change From Baseline in Vital Signs Parameters		Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11
Secondary	Number of Participants With Clinically Significant Findings in Physical examinations		Baseline and Day 11