IRCT20180620040164N16Recruiting未知
Comparative bioequivalence study of Gabapentin 300 mg Capsule of Dorsa Pharmaceutical Co. and PFIZER Inc. in 24 healthy male under fasting
Dorsa Pharmaceutical Co.0 sites26 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 45 years (—)
- Sex
- Male
Inclusion Criteria
- •Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
- •Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
- •Subjects with normal ECG and vital signs.
- •Subjects who agree with patient consent form.
- •Non-smoking at least for 10 hours before study.
Exclusion Criteria
- •Known hypersensitivity or idiosyncratic reaction to gabapentin or inactive ingredients.
- •Subjects with a known history of allergic reaction or drug intolerance.
- •History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.
- •Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
- •Subjects who have a history of alcohol or substance abuse within the last year.
- •Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
- •A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.
Investigators
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