Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study

Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as the Content of 1 x 150 mg Extended-Release Capsule Mixed With Applesauce in Healthy Subjects Under Fasting Conditions.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Venlafaxine Hydrochloride; Drug: Effexor® XR

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 postmenopausal or surgically sterilized.

Exclusion Criteria:

• Clinically significant illness 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 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 greater than 30.0.
• History of significant alcohol abuse within 6 months of the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit is equal to 150 mL of wine, 360mL 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, PCP, 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 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, unresolved gastrointestinal symptoms, 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 within 7 days prior to administration of study medication, except for topical products without systemic exposure.
• Positive alcohol breath test at screening.
• Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
• Any food allergies, 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 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 within 7 days prior to administration of the study medication.
• Subjects with clinically significant presence or history of raised intra-ocular pressure or at the risk of acute narrow angle glaucoma.
• Subjects who have dentures or braces.
• Intolerance to venipunctures.
• Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, or psychosis will not be eligible for this study.
• Subjects who are unable to understand or unwilling to sign the Informed Consent Form.
• Subjects with the known presence of volume-depletion.
• Subjects predisposed to bleeding of the skin and mucous membrane (impaired platelet aggregation).
• Subjects with clinically significant history of seizures.

• Additional exclusion criteria for females only:

  • Breastfeeding subjects.
  • Positive urine pregnancy test screen at screening.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference Listed Drug; Effexor® XR 150 mg Extended-Release Capsules	Drug: Effexor® XR; 150 mg Extended-Release Capsule; Other Names: Venlafaxine Hydrochloride (generic name)
Experimental: Investigational Test Product; Venlafaxine Hydrochloride 150 mg Extended-Release Capsules.	Drug: Venlafaxine Hydrochloride; 150 mg Extended-Release Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Venlafaxine.	Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).	Blood samples collected over a 48 hour period.
AUC0-t of Venlafaxine.	Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).	Blood samples collected over a 48 hour period.
AUC0-inf of Venlafaxine.	Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).	Blood samples collected over a 48 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2011
• Last Update Submitted That Met QC Criteria: February 11, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: 30024