Evidence map›Paper›PMID 39487337›Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2025

Pharmacokinetic Drug-Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants.

Dong Ho Kim, Jang Hee Hong, Won Tae Jung, Kyu-Yeol Nam, Jae Seok Roh, Hye Jung Lee, JungHa Moon, Kyu Yeon Kim, Jin-Gyu Jung, Jung Sunwoo

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06568133 (An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201603 and UIC201604 in Healthy Volunteers), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06568133 phase1completednot on this map

An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201603 and UIC201604 in Healthy Volunteers

TypeinterventionalSponsorKorea United Pharm. Inc.Ran2017 to 2018Enrolled57ConditionsHealthyArmsUIC201603 and co-administration of UIC201603 and UIC201604, UIC201604 and co-administration of UIC201603 and UIC201604
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Dong Ho KimClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.ORCID http://orcid.org/0009-0007-3181-8680
Jang Hee HongClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.ORCID http://orcid.org/0000-0002-0623-5455
Won Tae JungKorea United Pharmaceutical Corporation, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-6839-4670
Kyu-Yeol NamKorea United Pharmaceutical Corporation, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-9601-6178
Jae Seok RohKorea United Pharmaceutical Corporation, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-3614-7245
Hye Jung LeeCaleb Multilab Inc., Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-5358-8715
JungHa MoonCaleb Multilab Inc., Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-3328-1473
Kyu Yeon KimCaleb Multilab Inc., Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-1708-9932
Jin-Gyu JungDepartment of Family Medicine, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea. jjg72@cnuh.co.kr.ORCID http://orcid.org/0000-0002-2591-4867
Jung SunwooClinical Trials Center, Chungnam National University Hospital, 266 Munhwa-ro, Jung-gu, Daejeon, Republic of Korea. swj4991@cnuh.co.kr.ORCID http://orcid.org/0000-0001-8801-0323

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesCilostazol improves ischemic symptoms and prevents recurrence following cerebral infarction, and rosuvastatin reduces cholesterol levels. However, no reports exist on the pharmacokinetic interactions between these two drugs in healthy adults. This study evaluated the pharmacokinetic (PK) interactions and safety of cilostazol and rosuvastatin when co-administered to healthy male participants.

methodsA randomized, open-label, multiple-dosing, two-arm, two-period study was conducted. Arm A had 30 participants receiving 200 mg cilostazol daily and arm B had 27 participants receiving 20 mg rosuvastatin daily for 7 days. In period 2, both arms received a combination of 200 mg cilostazol and 20 mg rosuvastatin daily for 7 days following a 7-day washout period. Plasma concentrations of cilostazol, its metabolites, and rosuvastatin were quantified using liquid chromatography-tandem mass spectrometry.

resultsFifty-seven participants were randomized, and 44 completed the study. The geometric mean ratio (GMR) and 90% confidence intervals (CI) for maximum plasma concentration at steady state (C

conclusionThe repeated co-administration of cilostazol and rosuvastatin in healthy male participants resulted in minor PK interactions and exhibited a safety and tolerability profile similar to those of the individual drugs. This suggested that the combined regimen is well tolerated and does not necessitate dose adjustments. REGISTRATION: ClinicalTrials.Gov identifier no. NCT06568133.

Indexed as

CilostazolHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumTetrazolesAdultArea Under CurveChromatography, LiquidDrug InteractionsHealthy VolunteersHumansMaleMiddle AgedTandem Mass SpectrometryYoung AdultCilostazolHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumTetrazoles

Identifiers

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.