To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

Healthy Clinical Trial

Official title:

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351840
• Other study ID #: JWP-PVA-101
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: April 2022
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination

Description:

The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 15, 2021
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.

• Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent

Exclusion Criteria:

• Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.

• Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LivaloV
Treatment A, Tablet, Oral, QD for 7 Days
• A
Treatment B, Tablet, Oral, QD for 10 Days
• LivaloVA
Treatment C, Tablet, Oral, QD for 7 Days

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center, Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Pharmacokinetics(PK) parameters AUCss,t	AUCss,t in a steady-state after multiple-dose (single or combined administration).	0~24 hours
Primary	The Pharmacokinetics(PK) parameters Css,max	Css,max in a steady-state after multiple-dose (single or combined administration).	0~24 hours