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Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin

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ClinicalTrials.gov Identifier: NCT03116516
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE April 21, 2017
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast [ Time Frame: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs ]
Cmax, AUClast
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • Telmisartan Cmax [ Time Frame: 0 - 72 hrs ]
    Telmisartan Cmax during 0 - 72 hrs
  • Telmisartan AUClast [ Time Frame: 0 - 72 hrs ]
    Telmisartan AUClast during 0 - 72 hrs
  • Amlodipine Cmax [ Time Frame: 0 - 168 hrs ]
    Amlodipine Cmax during 0 - 168 hrs
  • Amlodipine AUClast [ Time Frame: 0 - 168 hrs ]
    Amlodipine AUClast during 0 - 168 hrs
  • Rosuvastatin Cmax [ Time Frame: 0 - 48 hrs ]
    Rosuvastatin Cmax during 0 - 48 hrs
  • Rosuvastatin AUClast [ Time Frame: 0 - 48 hrs ]
    Rosuvastatin AUClast during 0 - 48 hrs
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin
Official Title  ICMJE A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
Brief Summary

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers

Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.

Detailed Description

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.

In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.

In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A randomized, open-label, single dose, crossover clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: Temisartan/Amlodipine+Rosuvastatin
    All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
    Other Name: Twynsta Tab.+Crestor Tab.
  • Drug: YHP1604
    All subjects will receive a single oral dose of YHP1604 administered in the morning.
    Other Name: FDC
Study Arms  ICMJE
  • ARM1
    In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
    Interventions:
    • Drug: Temisartan/Amlodipine+Rosuvastatin
    • Drug: YHP1604
  • ARM2
    In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
    Interventions:
    • Drug: Temisartan/Amlodipine+Rosuvastatin
    • Drug: YHP1604
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2017)
180
Actual Study Completion Date  ICMJE May 26, 2017
Actual Primary Completion Date May 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

Exclusion Criteria:

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing
  • Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Healthy male with body mass index(BMI) between 18.5 and 30kg/m2
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03116516
Other Study ID Numbers  ICMJE YHP1604-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yuhan Corporation
Study Sponsor  ICMJE Yuhan Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mingul Kim, MD Chonbuk National University Hospital
PRS Account Yuhan Corporation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP