Bioequivalence study of Gabapentin 300 mg Capsule in 24 healthy male under fasting conditions

Not Applicable

Recruiting

Conditions: Bioequivalence investigation of the generic Dorsa Pharmaceutical Co. Gabapentin 300 mg Capsule with brand NEURONTIN® PFIZER capsule..

Registration Number: IRCT20180620040164N16

Lead Sponsor: Dorsa Pharmaceutical Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 26

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).