Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Metformin SR 500mg; Drug: Rosuvastatin 10mg; Drug: HCP1201 500/10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02011633

HM-MERO-105

Details and patient eligibility

About

To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state, respectively.

Full description

An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg in Healthy Volunteers

Enrollment: 72 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

HCP1201, Part 1

Experimental group

Description:

Participants received a single oral dose of the HCP1201 500/10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Treatment:

Drug: HCP1201 500/10mg

Metformin and Rosuvastatin, Part1

Active Comparator group

Description:

Participants received a single oral dose of coadministration of Metformin SR 500 mg and Rosuvastatin 10 mg under fasting condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Treatment:

Drug: Rosuvastatin 10mg

Drug: Metformin SR 500mg

HCP1201, Part 2

Experimental group

Description:

Participants received a single oral dose of the HCP1201 500/10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Treatment:

Drug: HCP1201 500/10mg

Metformin and Rosuvastatin, Part 2

Active Comparator group

Description:

Participants received a single oral dose of coadministration of Metformin SR 500mg and Rosuvastatin 10mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2).

Treatment:

Drug: Metformin SR 500mg