Bioequivalence Study in Healthy Subjects by Using of Myungin Chlorpromazine HCl Tab. 100mg and Neomazine Tab. 100mg

• Sponsor: Whanin Pharmaceutical Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06154434
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 31.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subject	Drug: Neomazine Tab. 100mg; Drug: Myungin Chlorpromazine HCl Tab. 100mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open Label, Randomized, Fasting, Single-dose, Two-period Crossover Study to Compare the Bioequivalence of Neomazine Tab. 100mg and Myungin Chlorpromazine HCl Tab. 100mg After Oral Administration in Healthy Subjects.
• Actual Study Start Date: Dec 6, 2018
• Actual Primary Completion Date: Feb 12, 2019
• Actual Study Completion Date: Feb 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Drug: Neomazine Tab. 100mg; single-dose administered after a 10-hour overnight fast.; Drug: Myungin Chlorpromazine HCl Tab. 100mg; single-dose administered after a 10-hour overnight fast.
Experimental: Group B	Drug: Neomazine Tab. 100mg; single-dose administered after a 10-hour overnight fast.; Drug: Myungin Chlorpromazine HCl Tab. 100mg; single-dose administered after a 10-hour overnight fast.

Outcome Measures

Primary Outcome Measures

1. AUClast [Up to 72 hours]

2. Cmax [Up to 72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. Subject is willing to participate and to Sign written informed consent form

2. Female subjects of childbearing age who use contraception other than hormonal contraception.

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Whan In Pharm.	Seoul		Korea, Republic of

Sponsors and Collaborators

• Whanin Pharmaceutical Company

Investigators

• Principal Investigator: MINGYU PARK, Chungbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Whanin Pharmaceutical Company
• ClinicalTrials.gov Identifier: NCT06154434
• Other Study ID Numbers: DDS16-065BE
• First Posted: Dec 4, 2023
• Last Update Posted: Dec 4, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chlorpromazine

Study Results

No Results Posted as of Dec 4, 2023