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Completed

NCT Number: NCT03627936

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

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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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lorcaserin manufactured at Zofingen

Drug

Lorcaserin XR tablets manufactured at Zofingen.

Other names: BELVIQ XR, APD356

Lorcaserin manufactured at Kawashima

Drug

Lorcaserin XR tablets manufactured at Kawashima.

Other names: BELVIQ XR, APD356

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Lorcaserin

    Time frame: 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

  2. Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin

    Time frame: 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

  3. Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin

    Time frame: 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

  4. Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin

    Time frame: 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

  5. Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin

    Time frame: 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

  6. Terminal elimination phase half-life (t½) of Lorcaserin

    Time frame: 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 outcomes

  1. Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

    Time frame: Baseline up to 28 days after last dose of study drug (Day 35)

  2. Number of Participants With Markedly Abnormal Laboratory Values

    Time frame: Baseline up to Day 11

  3. Number of Participants With Change From Baseline in Vital Signs Parameters

    Time frame: Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11

  4. Number of Participants With Clinically Significant Findings in Physical examinations

    Time frame: Baseline and Day 11

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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