NCT06154434

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2019

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 23, 2023

Last Update Submit

December 3, 2023

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (2)

  • AUClast

    Up to 72 hours

  • Cmax

    Up to 72 hours

Study Arms (2)

Group A

EXPERIMENTAL
Drug: Chlorpromazine HCl 100mg Tablets

Group B

EXPERIMENTAL
Drug: Chlorpromazine HCl 100mg Tablets

Interventions

Chlorpromazine HCl 100mg TabletsDRUG

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

Group AGroup B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whan In Pharm.

Seoul, South Korea

Location

MeSH Terms

Interventions

Chlorpromazine

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • MINGYU PARK

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

December 6, 2018

Primary Completion

February 12, 2019

Study Completion

February 12, 2019

Last Updated

December 8, 2023

Record last verified: 2023-11

Locations

KR(1)