NCT02097511

Brief Summary

This is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started Dec 2013

Typical duration for phase_1 hypertension

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

December 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

1 month

First QC Date

March 25, 2014

Last Update Submit

February 23, 2015

Conditions

HypertensionPeripheral Artery Disease

Keywords

Drug-drug interactionPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of Metoprolol and metabolites

    Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings

    upto 12 hours after Metoprolol Tartrate 100 mg dosing

Secondary Outcomes (1)

  • Blood pressure and pulse rate changes

    Upto 12 hours after Metoprolol Tartrate 100 mg dosing

Study Arms (3)

Sarpogrelate pretreatment and Metoprolol

EXPERIMENTAL

Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days and Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day

Drug: Sarpogrelate pretreatmentDrug: SarpogrelateDrug: Metoprolol

Sarpogrelate and Metoprolol

ACTIVE COMPARATOR

Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day

Drug: SarpogrelateDrug: Metoprolol

Metoprolol only

ACTIVE COMPARATOR

Metoprolol Tartrate 100 mg once a day

Drug: Metoprolol

Interventions

Sarpogrelate pretreatmentDRUG

Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days

Sarpogrelate pretreatment and Metoprolol
SarpogrelateDRUG

Sarpogrelate hydrochloride 100 mg three times a day

Sarpogrelate and MetoprololSarpogrelate pretreatment and Metoprolol
MetoprololDRUG

Metoprolol Tartrate 100 mg once a day

Metoprolol onlySarpogrelate and MetoprololSarpogrelate pretreatment and Metoprolol

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects aged 20 - 45 years
  • With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
  • Agreement with written informed consent

You may not qualify if:

  • Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
  • Inadequate result of laboratory test (especially, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
  • Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
  • Taking OTC(Over the counter)medicine including oriental medicine within 7 days
  • Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
  • Subject with known for hypersensitivity reaction to Metoprolol or Sarpogrelate
  • Previous whole blood donation within 60 days or component blood donation within 30 days
  • Previous participation of other trial within 90 days
  • Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
  • An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, 433-721, South Korea

Location

MeSH Terms

Conditions

HypertensionPeripheral Arterial Disease

Interventions

sarpogrelateMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Doo-Yeoun Cho, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 27, 2014

Study Start

December 1, 2013

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

KR(1)