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NCT Number: NCT04849026

Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18

This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Whan In Pharm.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Males and females adults aged 20 to 65 years
  • Diagnosed as schizophrenia prior to the screening visit
  • On treatment with a stable dose of clozapine 200 mg/day for at least 12 weeks before the screening visit and taken at 100 mg twice daily during the study period

Main Exclusion Criteria:

  • Subjects who have a medical history specified in protocol
  • Subjects with confirmed abnormal laboratory values specified in protocol
  • Subjects who have a medication history or safety risks specified in protocol
  • Subjects who can not comply with requirements of pharmacokinetic sampling as per protocol
  • Subjects who are expected to have the prohibited concomitant medication therapy during the study period
  • Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
  • Subjects who are not suitable for the clinical trial

Treatment and study plan

Clozaril 100 mg (Clozapine)

Drug

2 Doses/Day for 10 days

WID-CLZ18

Drug

2 Doses/Day for 10 days

Primary outcomes

  1. Cmax

    Time frame: Up to 12 hours

    Maximum blood concentration in steady state

  2. AUC0-12

    Time frame: Up to 12 hours

    Area under the concentration-time curve from zero to 12 hours at steady state

Secondary outcomes

  1. Tmax

    Time frame: Up to 12 hours

    Time to maximum blood concentration

  2. T1/2

    Time frame: Up to 12 hours

    Terminal elimination half life

  3. R

    Time frame: Up to 12 hours

    Accumulation rate

  4. Cmin

    Time frame: Up to 12 hours

    Steady-state peak plasma concentration

  5. Fluctuation

    Time frame: Up to 12 hours

    (Cmax-Cmin)/Cav

Sponsors and collaborators

Lead sponsor

Whanin Pharmaceutical Company

Industry

Registry information

Official study title

A Randomized, Open Label, Multiple-dose, 2-way Crossover, Phase I Study to Compare the Safety and Pharmacokinetics Profile of WID-CLZ18 and Clozaril 100 mg Tablet (Clozapine) After Oral Administration in Schizophrenia Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
May 16, 2023

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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