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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2018-09-02

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Lorcaserin manufactured at Zofingen

Intervention Type DRUG

Lorcaserin XR tablets manufactured at Zofingen.

Lorcaserin manufactured at Kawashima

Intervention Type DRUG

Lorcaserin XR tablets manufactured at Kawashima.

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

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.

Group Type EXPERIMENTAL

Lorcaserin manufactured at Zofingen

Intervention Type DRUG

Lorcaserin XR tablets manufactured at Zofingen.

Lorcaserin manufactured at Kawashima

Intervention Type DRUG

Lorcaserin XR tablets manufactured at Kawashima.

Interventions

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Lorcaserin manufactured at Zofingen

Lorcaserin XR tablets manufactured at Zofingen.

Intervention Type DRUG

Lorcaserin manufactured at Kawashima

Lorcaserin XR tablets manufactured at Kawashima.

Intervention Type DRUG

Other Intervention Names

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BELVIQ XR APD356 BELVIQ XR APD356

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes