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Completed

NCT Number: NCT06154434

Bioequivalence Study in Healthy Subjects by Using of Chlorpromazine HCl 100mg Tablets

This clinical study is an open label, randomized, fasting condition, single-dose, two-period crossover study to compare the bioequivalence of Chlorpromazine HCl 100mg Tablets after oral administration in healthy subjects.

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Key information

Conditions

Healthy Subject

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Whan In Pharm.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Main Inclusion Criteria:

  • Healthy subjects, over the age of 19 years old
  • Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.
  • All subjects should be judged normal and healthy during a pre-study medical evaluation
  • Subjects who has no birth or chronic disease and must be in good health as determined by physical exmination and medical tests including biochemistry, urinalysis, serology and hematology etc in serum/urine.
  • Subject is willing to participate and to Sign written informed consent form
  • Female subjects of childbearing age who use contraception other than hormonal contraception.
  • Subjects who has no history of psychical disorder within the last five years

Main Exclusion Criteria:

  • Subjects who have a medical history specified in protocol
  • Subjects who are expected to have the prohibited medication and activity etc. during the study period
  • Subjects who can not comply with requirements as per protocol
  • 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

Chlorpromazine HCl 100mg Tablets

Drug

single-dose administered after a 10-hour overnight fast.

Primary outcomes

  1. AUClast

    Time frame: Up to 72 hours

  2. Cmax

    Time frame: Up to 72 hours

Sponsors and collaborators

Lead sponsor

Whanin Pharmaceutical Company

Industry

Registry information

Official study title

An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Chlorpromazine HCl 100mg Tablets After Oral Administration in Healthy Subjects.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2023
Registry last updated
Dec 8, 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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