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PK/PD Clinical Trial of YYD601 in Healthy Adult Male

Sponsor
Yooyoung Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03558477
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
4.6
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each arm is assignted 10 persons[the percent of each arm is (treatmnet: comparator=4:1)]Each arm is assignted 10 persons[the percent of each arm is (treatmnet: comparator=4:1)]
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 19, 2017
Actual Primary Completion Date :
Feb 7, 2018
Actual Study Completion Date :
Feb 7, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Set 1(YYD601 1 & Nexium)

Set 1: YYD601 1 & Nexium

Drug: YYD601 1
YYD601 1

Drug: Nexium
Nexium
Experimental: Set 2(YYD601 2 & Nexium)

Set 2: YYD601 2 & Nexium

Drug: YYD601 2
YYD601 2

Drug: Nexium
Nexium
Experimental: Set 3(YYD601 3 & Nexium)

Set 3:YYD601 3 & Nexium

Drug: YYD601 3
YYD601 3

Drug: Nexium
Nexium

Outcome Measures

Primary Outcome Measures

  1. half-life [Evaluate the before/after treatment period(5 days per phase)]

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) half-life(after single dose), (after repeated dose)

  2. Tmax [Evaluate the before/after treatment period(5 days per phase)]

    Blood sampling time: 1d, 5d, 12d, 16d(each 17 times) Tmax(after singlidose), Tmax.ss(after repeated dose)

  3. Concentration [Evaluate the before/after treatment period(5 days per phase)]

    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)

  4. AUC [Evaluate the before/after treatment period(5 days per phase)]

    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)

Secondary Outcome Measures

  1. Percent of pH>4 duration time [Evaluate the before/after treatment period(5 days per phase)]

    pH>4 duration time

  2. % change in serum gastrin level [Evaluate the before/after treatment period(5 days per phase)]

    serum gastrin level

Other Outcome Measures

  1. Adverse event monitoring check up the adverse events [Evaluate the before/after treatment period(5 days per phase)]

    Adverse events

  2. Adverse event monitoring check up the vital sign(blood-pressure, pulse rate, temparature) [Evaluate the before/after treatment period(5 days per phase)]

    vital sign(blood-pressure, pulse rate, temparature)

  3. Adverse event monitoring check up the 12-lead EKG [Evaluate the before/after treatment period(5 days per phase)]

    12-lead EKG

  4. Adverse event monitoring check up the clinical laboratory test [Evaluate the before/after treatment period(5 days per phase)]

    clinical laboratory test

  5. Adverse event monitoring check up the physical [Evaluate the before/after treatment period(5 days per phase)]

    physical

  6. Adverse event monitoring check up the administraton about the combined drugs [Evaluate the before/after treatment period(5 days per phase)]

    administraton about the combined drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyungpook national university hospital Daegu Korea, Republic of

Sponsors and Collaborators

  • Yooyoung Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03558477
Other Study ID Numbers:
  • YYPCT_YYD601_P1
First Posted:
Jun 15, 2018
Last Update Posted:
Jun 15, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Esomeprazole

Study Results

No Results Posted as of Jun 15, 2018