CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers

March 9, 2015 updated by: Chong Kun Dang Pharmaceutical

CKD-391 in Healthy Volunteers to Investigate the Pharmacokinetic Drug Interaction Between Atorvastatin an Ezetimibe After Oral Administration

A randomized open-label, multiple dose, three-treatment, three-period, six-sequence, crossover study to investigate the pharmacokinetic drug interaction between Atorvastatin and Ezetimibe after oral administration in healthy volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outcome Measures

  1. Primary endpoint AUCτ,ss, Cmax,ss of atorvastatin and free ezetimibe
  2. Second endpoint 1) AUCinf,ss, Cavg,ss, %fluctuation, tmax,ss, t1/2, CL/Fss, Vd/Fss of atorvastatin and free ezetimibe 2) AUCτ,ss, AUCinf,ss, Cmax,ss, tmax,ss, t1/2, metabolic ratio of 2-hydroxy atorvastatin and free ezetimibe

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age Eligible for Study : 19 Years to 45 Years
  2. If males, Body weight ≥ 55kg, If females, Body weight ≥ 50kg
  3. BSA ≥ 18.5, <25
  4. Accepts healthy volunteers
  5. If female, Negative for pregnancy test at the screening and pre dose of Day 1
  6. The subjects who agree with performing contraception during the study
  7. The subjects who agreed with written informed consent

Exclusion Criteria:

  1. The subjects with impaired hepatic function, renal function, nervous system etc.
  2. The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
  3. The subjects with high blood pressure or low blood pressure (Systolic blood pressure>150mmHg or <90mmHg, Diastolic blood pressure>100mmHg or <50mmHg
  4. The subjects with abnormal Laboratory test (AST, ALT>1.25 fold of upper normal limit, Total bilirubin>1.5 fold of upper normal limit, CPK>2 fold of upper normal limit, Estimated Glomerular filtration rate<60mL/min/1.73m2 by Modification of Diet in Renal disease formula
  5. The subjects have drug abuse history within 1year or Positive for urine drug test at screening
  6. The subjects who took prescription only medicine whch can be effected in metabolism of Investigational product within 14days
  7. The subjects who took over the counter drug whch can be effected in metabolism of Investigational product within 7days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1(Lipitor®>Ezetrol®>Lipitor®, Ezetrol®)

Three treatment

  1. atorvastatin calcium 40mg will be administration to healthy volunteers during 7days
  2. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
Drug: 1 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg
Drug: 1 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Drug: 1 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Experimental: 2(Ezetrol®>Lipitor®, Ezetrol®>Lipitor®)

Three treatment

  1. ezetimibe 10mg will be administered to healthy volunteers during 7days
  2. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
Drug: 2 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Drug: 2(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Drug: 2 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg
Experimental: 3(Lipitor®, Ezetrol®>Lipitor®>Ezetrol®)

Three treatment

  1. atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
  2. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
Drug: 3(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Drug: 3 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg
Drug: 3 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Experimental: 4(Lipitor®>Lipitor®, Ezetrol®>Ezetrol®)
  1. atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
  2. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
Drug: 4 (Lipitor®)
atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg
Drug: 4(Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Drug: 4 (Ezetrol®)
After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Experimental: 5(Ezetrol®>Lipitor®>Lipitor®, Ezetrol®)
  1. ezetimibe 10mg will be administered to healthy volunteers during 7days
  2. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
Drug: 5 (Ezetrol®)
ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Drug: 5 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg
Drug: 5 (Lipitor®, Ezetrol®)
After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Experimental: 6(Lipitor®, Ezetrol®>Ezetrol®>Lipitor®)
  1. atorvastatin calcium 40mg and ezetimibe 10mg will be administered to healthy volunteers during 7days
  2. after 11days withdrawal period, ezetimibe 10mg will be administered to healthy volunteers during 7days
  3. after 11days withdrawal period, atorvastatin calcium 40mg will be administered to healthy volunteers during 7days
Drug: 6(Lipitor®, Ezetrol®)
atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg, Ezetrol® 10mg
Drug: 6 (Ezetrol®)
After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
Other Names:
  • Ezetrol® 10mg
Drug: 6 (Lipitor®)
After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
Other Names:
  • Lipitor® 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCτ,ss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Cmax,ss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf,ss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Cavg,ss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
%fluctuation of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
tmax,ss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
t1/2 of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
CL/Fss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Vd/Fss of atorvastatin and free ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
AUCτ,ss of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
AUCinf,ss of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Cmax,ss of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
tmax,ss of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
t1/2 of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)
metabolic ratio of 2-hydroxy atorvastatin and total ezetimibe
Time Frame: common : just before the IP administration of D5(D22, D39), D6(D23, D40)
Atorvastatin single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 h Ezetimibe single : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h Atorvastatin+Ezetimibe : just before the IP administration of D7(D24, D41) and after the IP administration 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 h
common : just before the IP administration of D5(D22, D39), D6(D23, D40)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152DDI14016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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