Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg (NCT02952937) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Two Formulations of Pregabalin CR(Controlled-release) Table 300 mg
South Korea24 participantsStarted 2016-11
Plain-language summary
The purpose of this clinical trial is to (1) evaluate the bioequivalence(BE) of GLA5PR GLARS-NF3 tablet 300mg administered regular diet relative to GLA5PR GLARS-NF1 tablet 300mg administered regular diet and (2) determine the safety and tolerability of a single dose of GLA5PR GLARS-NF3 tablet 300mg administered regular diet and GLA5PR GLARS-NF1 tablet 300mg administered regular diet.
Who can participate
Age range19 Years
SexMALE
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Inclusion Criteria:
* Healthy male subjects who, at the time of screening, are the age of older than 19 years.
* Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg.
* There is no congenital disease or within 3 years of chronic diseases.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests.
* Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products.
* A subject who has the following clinical laboratory test results
☞ Liver Function Test (AST, ALT) \> three tim…