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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Lorcaserin manufactured at Kawashima; Drug: Lorcaserin manufactured at Zofingen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03627936

APD356-A001-040

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)

Experimental group

Description:

Participants will receive a single oral dose of lorcaserin 20 milligram (mg) XR tablets manufactured at Zofingen (A) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Kawashima (B) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods.

Treatment:

Drug: Lorcaserin manufactured at Zofingen

Drug: Lorcaserin manufactured at Kawashima

Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A)

Experimental group

Description:

Participants will receive a single oral dose of lorcaserin 20 mg XR tablets manufactured at Kawashima (B) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Zofingen (A) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods.

Treatment:

Drug: Lorcaserin manufactured at Zofingen

Drug: Lorcaserin manufactured at Kawashima