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CompletedNCT02011633Updated Mar 11, 2014

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

A Phase 1 interventional study of HCP1201 500/10mg and Metformin SR 500mg in Diabetes Mellitus, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in South Korea. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-11.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 189 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Browse Hanmi Pharmaceutical Company Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    HCP1201, Part 1

    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

  • Active comparator
    Metformin and Rosuvastatin, Part1

    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 500mg · Drug: Rosuvastatin 10mg

  • Experimental
    HCP1201, Part 2

    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

  • Active comparator
    Metformin and Rosuvastatin, Part 2

    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

  • DrugHCP1201 500/10mg

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

  • DrugMetformin SR 500mg

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

    Also known as: Glucophage SR 500 mg

  • DrugRosuvastatin 10mg

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

    Also known as: Crestor 10mg

06

What researchers measure

Primary outcomes

  1. metformin, rosuvastatin Cmax

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  2. metformin, rosuvastatin AUClast

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

Secondary outcomes

  1. Metformin, rosuvastatin Tmax

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  2. Metformin, rosuvastatin T1/2

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

  3. Metformin, rosuvastatin AUCinf

    Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Nov 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2013
First posted
Dec 13, 2013
Start
Oct 2013
Primary completionActual
Nov 2013
CompletionActual
Dec 2013
Last update
Mar 11, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02011633
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Dec 13, 2013
Start date
Oct 2013
Primary completion
Nov 2013
Completion
Dec 2013
Last update
Mar 11, 2014

Study contacts

Wooseong Huh, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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