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Venlafaxine 25 mg Tablets Under Non-Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Venlafaxine 25 mg Tablets (Drug); Effexor® 25 mg Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Eric Bicrell, M.D., Principal Investigator, Affiliation: Anapharm

Summary

The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fed conditions.

Clinical Details

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Venlafaxine 25 mg Tablets and Effexor® 25 mg Tablets Administered as 1 x 25 mg Tablet in Healthy Subjects Under Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration - Venlafaxine in Plasma

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma

Secondary outcome:

Cmax - O-Desmethylvenlafaxine in Plasma

AUC0-inf - O-desmethylvenlafazine in Plasma

AUC0-t - O-desmethylvenlafaxine in Plasma

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects will be females and/or males, non-smokers, 18 years of age and older. Female

subjects will be post-menopausal or surgically sterilized.

- Post-menopausal status is defined as absence of menses for the past 12 months or

hysterectomy with bilateral oophorectomy at least 6 months ago.

- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation

at least 6 months ago. Exclusion Criteria:

- Clinically significant illnesses within 4 weeks of the administration of study

medication.

- Clinically significant surgery within 4 weeks of the administration of study

medication.

- Any clinically significant abnormality found during medical screening.

- Any reason which, in the opinion of the medical sub-investigator, would prevent the

subject from participating in the study.

- Abnormal laboratory tests judged clinically significant.

- Positive urine drug screen at screening.

- Positive testing for hepatitis B, hepatitis C, or HIV at screening.

- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic

blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.

- Subjects with BMI ≥ 30. 0.

- History of significant alcohol abuse within six months of the screening visit or any

indication of the regular use of more than fourteen units of alcohol per week (1 Unit

- 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).

- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)

within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.

- History of allergic reactions to venlafaxine.

- History of allergic reactions to heparin.

- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of

inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.

- Use of an investigational drug or participation in an investigational study within 30

days prior to administration of the study medication.

- History or presence of any clinically significant gastrointestinal pathology (e. g.

chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e. g. diarrhea, vomiting), liver or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.

- Any history or presence of clinically significant neurological, endocrinal,

cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

- Use of prescription medication within 14 days prior to administration of study

medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.

- Positive alcohol breath test at screening.

- Subjects who have used tobacco in any form within the 90 days preceding study drug

administration.

- Intolerance to venipuncture.

- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,

diabetes, psychosis, or glaucoma will not be eligible for this study.

- Subjects who are unable to understand or unwilling to sign the Informed Consent Form.

- Any food allergy, intolerance, restriction or special diet that, in the opinion of

the medical sub-investigator, contraindicates the subject's participation in this study.

- Subjects who have had a depot injection or an implant of any drug 3 months prior to

administration of study medication.

- Donation of plasma (500 mL) within 7 Days. Donation or loss of whole blood prior to

administration of the study medication as follows: less than 300 mL of whole blood within 30 days or; 300 mL to 500 mL of whole blood within 45 days or; more than 500 mL of whole blood within 56 days.

- Subjects who have consumed food or beverages containing grapefruit (e. g. fresh,

canned, or frozen) within 7 days prior to administration of the study medication.

- Subjects with known presence of volume-depletion.

- Subjects predisposed to bleeding of the skin and mucous membrane.

- Subjects with history or known presence of impaired platelet aggregation.

- Subjects with history of seizures.

- Breast-feeding subjects.

- Positive urine pregnancy test at screening (performed on all females).

Locations and Contacts

Anapharm Inc., Montreal, Quebec H3X 2H9, Canada

Anapharm Inc., Sainte-Foy, Quebec GIV2K8, Canada

Additional Information

Starting date: December 2002
Last updated: September 11, 2009

Page last updated: August 23, 2015

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