Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study

NCT01282814 | Completed Phase 1 Results

• 1 other identifier: 30024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Investigational Test Product

EXPERIMENTAL

Venlafaxine Hydrochloride 150 mg Extended-Release Capsules.

Drug: Venlafaxine Hydrochloride

Reference Listed Drug

ACTIVE COMPARATOR

Effexor® XR 150 mg Extended-Release Capsules

Drug: Effexor® XR

Interventions

Venlafaxine Hydrochloride DRUG

150 mg Extended-Release Capsule

Investigational Test Product

Effexor® XR DRUG

150 mg Extended-Release Capsule

Also known as: Venlafaxine Hydrochloride (generic name)

Reference Listed Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: Teva Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Benoit Girard, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: February 1, 2003
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: March 8, 2011
• Results First Posted: March 8, 2011

Record last verified: 2011-02

Locations

CA (1)