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CompletedNCT02566187Updated Feb 25, 2016

A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

A Phase 1 interventional study of Fimasartan/Atorvastatin Combination Tablet and Fimasartan in Hypertension and Hyperlipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in South Korea. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

02

Conditions studied

  • Hypertension
  • Hyperlipidemia
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 99 is close to the median of 90 across 5,095 interventional studies indexed under Hypertension.

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Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years to 50 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

  • a Healthy male subject, aged 19- 50 years

Exclusion criteria

Exclusion Criteria:

  • History of clinically significant hypersensitivity to study drug, any other drug
  • Hypotension or hypertension
  • Active liver disease
  • History of gastrointestinal disease
  • History of excessive alcohol abuse
  • Participation in any other study within 3 months
05

Study design

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

Study arms

  • Other
    Group 1

    Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.

    Drug: Fimasartan/Atorvastatin Combination Tablet · Drug: Fimasartan · Drug: Atorvastatin

  • Other
    Group 2

    Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.

    Drug: Fimasartan/Atorvastatin Combination Tablet · Drug: Fimasartan · Drug: Atorvastatin

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin

    Time frame: 0~48 hour after medication

  2. Area under the curve(AUCt) of Fimasartan and Atorvastatin

    Time frame: 0~48 hour after medication

07

Study locations

1 site
  • Inje University Busan Paik Hospital
    Busan, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02566187
Responsible party
Sponsor
First posted
Oct 2, 2015
Start date
Aug 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Feb 25, 2016

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fimasartan · Atorvastatin

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