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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: HCP1201 500/10mg; Drug: Metformin SR 500mg; Drug: Rosuvastatin 10mg

• Registration Number: NCT02011633
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCP1201, Part 1	HCP1201 500/10mg	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).
HCP1201, Part 2	HCP1201 500/10mg	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).
Metformin and Rosuvastatin, Part1	Metformin SR 500mg	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).
Metformin and Rosuvastatin, Part 2	Metformin SR 500mg	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).
Metformin and Rosuvastatin, Part1	Rosuvastatin 10mg	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).

Primary Outcome Measures

Name	Time	Method
metformin, rosuvastatin AUClast	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
metformin, rosuvastatin Cmax	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Secondary Outcome Measures

Name	Time	Method
Metformin, rosuvastatin Tmax	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin T1/2	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h
Metformin, rosuvastatin AUCinf	pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of