Bioequivalence Study of Neurogabin-M (Gabapentin 400 mg) Capsule With Parketin (Gabapentin 400 mg) Capsules

• Status: Completed
• Trial end date: 2013-09-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose bioequivalence study.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Karachi
• Collaborators: Center for Bioequivalence Studies and Clinical Research (CBSCR), HEJ Research Institute of chemistry, University of Karachi; Merck Pvt. Ltd, Pakistan
• Treatments: Gabapentin

Criteria

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.