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OpenTrials
Completed

NCT Number: NCT02933658

Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Completed

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Key information

Conditions

Hypertension and Dyslipidemia Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male who are ≥19, <50 years old
  • Man who weights over 55kg and whose BMI is 18~30(kg/m2)
  • Man who doesn't have any chronic disease or history of disease

Exclusion criteria

  • man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Treatment and study plan

Telmisartan

Drug

Amlodipine

Drug

Rosuvastatin

Drug

Primary outcomes

  1. AUC of Reference 1

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  2. Cmax of Reference 1

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  3. AUC of Reference 2

    Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  4. Cmax of Reference 2

    Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
First posted
Oct 14, 2016
Registry last updated
Oct 14, 2016

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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