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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Metformin SR 750mg; Drug: HCP1201 750/10mg; Drug: Rosuvastatin 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02026817

HM-MERO-104

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 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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36 participants in 2 patient groups

HCP1201

Experimental group

Description:

Participants received a single oral dose of the HCP1201 750/10 mg 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 750/10mg

Metformin and Rosuvastatin

Active Comparator group

Description:

Participants received a single oral dose of coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg under fed 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 750mg