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An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers
Full description
A phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening before 28days of first administration. Subjects administrate Lafutidine bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.
Enrollment
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Inclusion criteria
Healthy subjects between the ages of 19 and 50 at the screening
Male subjects whose weight is greater than 55kg Female subjects whose weight is greater than 50kg and within ±20% range of ideal body weight.
Ideal body weight(kg) = (Height(cm) - 100) * 0.9
For female subjects must show negative for urine pregnancy test and also must meet one of the below listed criteria:
A sexually active male subjects must use and accepted method of contraception during the course of the clinical study and must not donate sperms until a month after finishing drug administration. (If male subjects oneself or female partner is sterility, that does not apply.)
Subjects who understand the clinical study completely, agree to participate and sign written consent form for conduct precautions
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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