NCT02011633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

December 10, 2013

Last Update Submit

March 10, 2014

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (4)

HCP1201, Part 1

EXPERIMENTAL

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).

Drug: HCP1201 500/10mg

Metformin and Rosuvastatin, Part1

ACTIVE COMPARATOR

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).

Drug: Metformin SR 500mgDrug: Rosuvastatin 10mg

HCP1201, Part 2

EXPERIMENTAL

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).

Drug: HCP1201 500/10mg

Metformin and Rosuvastatin, Part 2

ACTIVE COMPARATOR

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).

Drug: Metformin SR 500mg

Interventions

HCP1201 500/10mgDRUG

500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.

HCP1201, Part 1HCP1201, Part 2
Metformin SR 500mgDRUG

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Also known as: Glucophage SR 500 mg
Metformin and Rosuvastatin, Part 2Metformin and Rosuvastatin, Part1
Rosuvastatin 10mgDRUG

Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.

Also known as: Crestor 10mg
Metformin and Rosuvastatin, Part1

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wooseong Huh, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 13, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

KR(1)