NCT02933658

Brief Summary

A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P75+ for phase_1

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

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

October 12, 2016

Last Update Submit

October 12, 2016

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (4)

  • AUC of Reference 1

    0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  • Cmax of Reference 1

    0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  • AUC of Reference 2

    0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

  • Cmax of Reference 2

    0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

Study Arms (2)

Reference1

EXPERIMENTAL

single(Reference1) -\> combination(Reference1+Reference2)

Drug: TelmisartanDrug: AmlodipineDrug: Rosuvastatin

Reference2

EXPERIMENTAL

single(Reference2) -\> combination(Reference1+Reference2)

Drug: TelmisartanDrug: AmlodipineDrug: Rosuvastatin

Interventions

TelmisartanDRUG
Reference1Reference2
AmlodipineDRUG
Reference1Reference2
RosuvastatinDRUG
Reference1Reference2

Eligibility Criteria

Age19 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male who are ≥19, \<50 years old
  • Man who weights over 55kg and whose BMI is 18\~30(kg/m2)
  • Man who doesn't have any chronic disease or history of disease

You may not qualify if:

  • man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

TelmisartanAmlodipineRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidines

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 14, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Last Updated

October 14, 2016

Record last verified: 2016-10