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Completed

NCT Number: NCT02026817

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg

To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteer, age 20~55 years
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 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.

Exclusion criteria

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.

Treatment and study plan

HCP1201 750/10mg

Drug

750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

Metformin SR 750mg

Drug

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Other names: Glucophage SR 750 mg

Rosuvastatin 10mg

Drug

Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Other names: Crestor 10mg

Primary outcomes

  1. metformin, rosuvastatin Cmax

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  2. metformin, rosuvastatin AUClast

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Secondary outcomes

  1. Metformin, rosuvastatin Tmax

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  2. Metformin, rosuvastatin T1/2

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  3. Metformin, rosuvastatin AUCinf

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 3, 2014
Registry last updated
Mar 11, 2014

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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