PK/PD Clinical Trial of YYD601 in Healthy Adult Male

GERD Clinical Trial

Official title:

A Dose Blocked-randomized, Open-label, Parallel Design Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Properties and Safety of YYD601 After Oral Administration in Healthy Adult Male Volunteers(Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558477
• Other study ID #: YYPCT_YYD601_P1
• Status: Completed
• Phase: Phase 1
• Start date: September 19, 2017
• Est. completion date: February 7, 2018

Study information

• Verified date: June 2018
• Source: Yooyoung Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A dose block-randomized, open-label, parallel clinical trial

Description:

This study to evaluate comparatively a characteristics and safety of the PK/PD of single/repeated oral administration YYD601 and Nexium tab and the effects of food influence the PK/PD of YYD601 in healthy adult male.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion criteria:

• Healthy adult male above 19 years old when getting a screening test.

• Subjects who have over 50kg weight, included in the IBW± 20% range. [IBW(kg)={height(cm)-100}x0.9

• Subjects who haven't any congenital or chronic disease, and any other disease following the medical examination.

• Subjects who are confirmed as a participant by the serum test, hematologital test, blood chemistry tests, urine tests, and clinical laboratory test, 12-lead EKG etc following the characteristics aboht the IP within the 3 weeks before investogator products are administrated.

• Subjects who voluntarily decide to participated in this trial after comletely understand about this clinical trial.

Exclusion criteria

• Subjects who are judged not suitable to participated in this trial.

• Other specific exlusion criteria is identified in the protocol.

Related Conditions & MeSH terms

• GERD

Intervention

Drug:
• YYD601 1
YYD601 1
• YYD601 2
YYD601 2
• YYD601 3
YYD601 3
• Nexium
Nexium

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event monitoring check up the adverse events	Adverse events	Evaluate the before/after treatment period(5 days per phase)
Other	Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature)	vital sign(blood-pressure, pulse rate, temparature)	Evaluate the before/after treatment period(5 days per phase)
Other	Adverse event monitoring check up the 12-lead EKG	12-lead EKG	Evaluate the before/after treatment period(5 days per phase)
Other	Adverse event monitoring check up the clinical laboratory test	clinical laboratory test	Evaluate the before/after treatment period(5 days per phase)
Other	Adverse event monitoring check up the physical	physical	Evaluate the before/after treatment period(5 days per phase)
Other	Adverse event monitoring check up the administraton about the combined drugs	administraton about the combined drugs	Evaluate the before/after treatment period(5 days per phase)
Primary	half-life	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)	Evaluate the before/after treatment period(5 days per phase)
Primary	Tmax	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)	Evaluate the before/after treatment period(5 days per phase)
Primary	Concentration	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Cmax(after singlidose), Cmax.ss(after repeated dose) Cmin.ss(after single dose),Cmin.ss(after single dose)	Evaluate the before/after treatment period(5 days per phase)
Primary	AUC	Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) AUClast(after singlidose), AUCt(after repeated dose) AUCinf(after single dose), AUCinf(after repeated dose)	Evaluate the before/after treatment period(5 days per phase)
Secondary	Percent of pH>4 duration time	pH>4 duration time	Evaluate the before/after treatment period(5 days per phase)
Secondary	% change in serum gastrin level	serum gastrin level	Evaluate the before/after treatment period(5 days per phase)