A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male … (NCT02493738) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
South Korea24 participantsStarted 2015-07
Plain-language summary
Study Objectives:
* To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
* To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
* To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects
Who can participate
Age range19 Years – 50 Years
SexMALE
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Inclusion criteria
✓. Korean male volunteers in the age between 19 and 50 years old (inclusive)
✓. Subject who are able to give signed informed consent
✓. Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg
✓. Subject who are considered
✓. Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.
Exclusion criteria
✕. History of allergy or sensitivity to any drug, including any prior serious adverse reaction to antifungal agent(s)
✕. History of congestive heart failure or Patients with ventricular dysfunction such as congestive heart failure
✕. Undergone surgery or who have a medical condition, that in the judgment of the Investigator, may affect absorption, distribution, metabolism or elimination of the drug product
✕. Participated in a previous clinical trial within 90 days prior to screening visit
✕. Donated blood or had a significant loss of blood within 60 days prior to screening visit
✕. Special diet or substantial changes in eating habits within 30 days prior to screening visit