NCT02561884

Brief Summary

To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2015

Status
unknown

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

First Submitted

Initial submission to the registry

September 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

September 24, 2015

Last Update Submit

September 25, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC

    0~72hr

  • Cmax

    0~72hr

Study Arms (2)

AB

EXPERIMENTAL

Olostar Tab. followed by Olmetec and Crestor

Drug: Olostar Tab.Drug: Co-administration of Olmetec and Crestor

BA

EXPERIMENTAL

Olmetec and Crestor followed by Olostar Tab.

Drug: Olostar Tab.Drug: Co-administration of Olmetec and Crestor

Interventions

Olostar Tab.DRUG
ABBA
Co-administration of Olmetec and CrestorDRUG
ABBA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 18.5 and ≤ 30.0 kg/m2.
  • No clinically significant findings in a 12-lead electrocardiogram (ECG)
  • Age 18-60 years at screening

You may not qualify if:

  • History of severe allergy or allergic reactions to the IMPs or related drugs
  • History of serious clinical illness that can impact fate of drugs including major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 28, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09