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CompletedNCT06154434Updated Dec 8, 2023

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

A Phase 1 interventional study of Chlorpromazine HCl 100mg Tablets in Healthy Subject, sponsored by Whanin Pharmaceutical Company. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Whanin Pharmaceutical Company · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Dec 2018, registered Nov 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Subject
03

In context

Lead sponsor

Whanin Pharmaceutical Company is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main Inclusion Criteria:

  1. Healthy subjects, over the age of 19 years old
  2. Weight: At least 50.0 kg and Body mass index (BMI) between 18.0-30.0 kg/m2.

  3. 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.
  4. Subject is willing to participate and to Sign written informed consent form
  5. Female subjects of childbearing age who use contraception other than hormonal contraception.
  6. Subjects who has no history of psychical disorder within the last five years

Main Exclusion Criteria:

  1. Subjects who have a medical history specified in protocol
  2. Subjects who are expected to have the prohibited medication and activity etc. during the study period
  3. Subjects who can not comply with requirements as per protocol
  4. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy
  5. Subjects who are not suitable for the clinical trial
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Group A

    Drug: Chlorpromazine HCl 100mg Tablets

  • Experimental
    Group B

    Drug: Chlorpromazine HCl 100mg Tablets

Interventions

  • DrugChlorpromazine HCl 100mg Tablets

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

06

What researchers measure

Primary outcomes

  1. AUClast

    Time frame: Up to 72 hours

  2. Cmax

    Time frame: Up to 72 hours

07

Study locations

1 site
  • Whan In Pharm.
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06154434
Lead sponsor
Whanin Pharmaceutical Company
Responsible party
Sponsor
First posted
Dec 4, 2023
Start date
Dec 6, 2018
Primary completion
Feb 12, 2019
Completion
Feb 12, 2019
Last update
Dec 8, 2023

Study contacts

MINGYU PARK
principal investigator · Chungbuk National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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