Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Healthy male volunteer, age 20~55 years
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- Healthy male volunteer, age 20~55 years
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Exclusion Criteria
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- 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.
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
Summary
- Conditions
- Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 55 years
- Gender
- Only males
Description
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
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
Inclusion Criteria
- Healthy male volunteer, age 20~55 years
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- Healthy male volunteer, age 20~55 years
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Exclusion Criteria
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- 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.
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
Tracking Information
- NCT #
- NCT02026817
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jung-Ryul Kim, MD, PhD Samsung Medical Center
- Jung-Ryul Kim, MD, PhD Samsung Medical Center
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