Healthy Volunteers Clinical Trial
— BEOfficial title:
Bioequivalence Study of Gabapentin 400 mg Capsule
Verified date | September 2022 |
Source | University of Karachi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 10, 2013 |
Est. primary completion date | July 5, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - All subjects should be healthy and free from any epidemic, contagious or measurable disease (e.g. Malaria, Dengue) - Age range for inclusion will be 18-50 year. - BMI for all Subjects will be between 18.5-30.0 kg/m2. - Participant capable of understanding the informed consent. - Non Smokers, who have not smoked in last 3 months. - Medical history, physical examination and screening tests must fall in normal range, unless the investigator considers the abnormality to be clinically not significant. - Clinically normal physical findings including ECG and safety laboratory values at the Screening visit and on Day -1 of each treatment period, including negative results for drugs of abuse, breath alcohol, Hepatitis B, Hepatitis C and HIV. - Participants (who can read and understand Urdu) should be able to give informed consent, understand and sign the Informed Consent Form. - Participants should have adequate organ function (i.e., kidney, liver and heart). - All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical screening procedures and at each study period check-in. Exclusion Criteria: - Any active allergic disease or a history of any significant allergic disease (e.g. Rhinitis, dermatitis, asthma). - Known hypersensitivity to Investigational drug(s). - Abnormal results of blood and urine tests conducted at screening unless the investigator considers an abnormality to be clinically irrelevant. - Presence or history of cardiac (e.g. Myocardial Infarction, arrythmia), renal (e.g. renal insufficiency) , hepatic (e.g. hepatic impairment) , organ insufficiency, bone marrow disease, hematological abnormality (e.g. leukemia, anemia), photosensitivity, neurological disorders) or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination (e.g. dysphagia, dyspepsia). - History or presence of any musculo skeletal disease (e.g. Tendonitis). - Subject donated blood (450ml) within 12 weeks minimum preceding the study. - Alcoholic or with a history of chronic alcohol intake or consumed alcohol or Gutka in last 3 months. - Ingestion of OTC drug, within 14 days of drug administration (e.g. aspirin, ibuprofen). - History of intake of any prescribed medicine (e.g. Captopril, Sumatriptan) during a period of 30 days, prior to drug administration day of study. - Ingestion of investigational drug within 30 days, prior to investigational drug administration in the study. - Ingestion of any known hepatic or renal clearance altering agents (e.g. erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 30 days, prior to study initiation. Drug interaction section at 5.10 and Warnings section at 5.11 should be considered. - Subjects with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study. - Subjects with known HIV, hepatitis B or C infection or autoimmune diseases. - History of drug exposure which, in the opinion of Investigator, amounts to drug abuse (e.g. Amphetamine). - Participation in other drug studies within three months prior to study initiation. - Subjects who is unable to or likely to be non-compliant with protocol requirements or restrictions. - Limited mental capacity to the extent that the subject is unable to provide legal consent and information regarding the side effects or tolerance of the study drug. - Pregnancy or breast feeding, women of child bearing age who are not using a recognized form of contraception for at least last 30 days or using hormonal contraception, are also excluded. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
University of Karachi | Center for Bioequivalence Studies and Clinical Research, Merck Pvt. Ltd, Pakistan |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | Maximum plasma concentration of Gabapentin | 0-36 hours post dose | |
Primary | AUC last (AUC 0-t) | Area under plasma concentration time curve from zero to time of the last measurable concentration | 0-36 hours post dose | |
Primary | AUC total (AUC 0-8) | Area under the plasma concentration-time curve from zero to infinity. | 0-36 hours post dose | |
Secondary | Tmax | Time to reach maximum drug concentration in plasma | 0-36 hours post dose |
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