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OpenTrials
Completed

NCT Number: NCT03247140

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers

The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers Volunteers

Completed

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Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Subject who has the ability and willingness to participate the whole period of trial

Exclusion criteria

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • Systolic BP > 140mmHG or Diastolic BP > 90mmHg)
  • AST or ALT > X 2 UNL
  • History of drug abuse or positive drug screening.
  • Participation in other drug studies within 3 months prior to the drug administration.
  • Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Treatment and study plan

JLP-1401

Drug

Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)

Telmisartan/Amlodipine, Rosuvastatin

Drug

Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)

Primary outcomes

  1. AUC

    Time frame: 72hr after baseline

    Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

  2. Cmax

    Time frame: 72 after baseline

    Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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