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Completed

NCT Number: NCT02166398

A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers

A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

About this study

A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients over 20 under 45 years of age
  • BMI state over 19 under 27

Exclusion criteria

  • mean sit SBP≥100mmHg or mean sit DBP≥150mmHg at screening
  • mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening
  • Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, has an intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason

Treatment and study plan

UI15AML055MT

Drug

tab, PO

Amosartan 5/50

Drug

tab, PO

Primary outcomes

  1. AUClast of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  2. AUCinf of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  3. Cmax of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  4. AUClast of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

  5. AUCinf of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

  6. Cmax of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

Secondary outcomes

  1. Tmax of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  2. t1/2 of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  3. CL/F of Amlodipine

    Time frame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  4. Tmax of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

  5. t1/2 of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

  6. CL/F of Losartan

    Time frame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose

Sponsors and collaborators

Lead sponsor

Korea United Pharm. Inc.

Industry

Registry information

Official study title

Phase 1 Study of Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg

Acronym: UI15AML055MT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2014
Registry last updated
Jun 12, 2015

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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