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Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fed 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 Hydrochloride (Drug); Effexor® XR (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

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

Summary

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fed conditions.

Clinical Details

Official title: Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as 1 x 150 mg Extended-Release Capsules 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 of Venlafaxine.

AUC0-t of Venlafaxine.

AUC0-inf of Venlafaxine.

Secondary outcome:

Cmax of O-Desmethylvenlafaxine.

AUC0-t of O-Desmethylvenlafaxine.

AUC0-inf of O-Desmethylvenlafaxine.

Eligibility

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

Criteria:

Inclusion Criteria:

- Members of the community at large.

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

- Female subjects will be post-menopausal or surgically sterilized.

Exclusion Criteria:

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

medication.

- Clinically significant surgery within 4 weeks prior to the administration of the

study medication.

- Any clinically significant abnormality found during medical screening.

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

pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

- History or presence of any clinically significant gastrointestinal pathology,

unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

- Subjects with raised intra-ocular pressure or at risk of acute narrow angle glaucoma.

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

- Subjects with a history of seizures.

- 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 at screening.

- Subjects with BMI > 30. 0.

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

indication of the regular use of more than fourteen units of alcohol per week (1 unit equals 150 mL of wine, 360 mL of beer, or 45 mL of alcohol 45%).

- 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 (cocaine, PCP, crack) within 1 year of the screening visit.

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

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

- History of allergic reactions to venlafaxine hydrochloride.

- History of allergic reactions to heparin.

- Use of any drugs know to induce or inhibit hepatic drug metabolism, use of an

investigational drug, or participation in an investigational study within 30 days prior to administration of the study medication.

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

medication or over-the-counter products within 7 days prior to the administration of study medication, except for topical products without systemic absorption.

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

administration of the study medication.

- Donation of plasma (500 mL) within 7 days of Period I dosing. 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.

- Positive alcohol breath test at screening.

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

administration.

- Subjects who have consumed food or beverages containing grapefruit within 7 days

prior to administration of the study medication.

- Intolerance to venipunctures.

- Additional exclusion criteria for females only:

- Breastfeeding subjects.

- Positive urine pregnancy test at screening.

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec G1V 2K8, Canada
Additional Information

Starting date: September 2002
Last updated: February 11, 2011

Page last updated: August 23, 2015

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