Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions

An Open Label, Balanced, Randomized, Two-treatment, Two-sequence Two-period, Single Dose Sprinkled on Apple Sauce, Crossover and Relative Bioavailability Study in Healthy Adult, Human Subjects Under Fed Conditions

The objective of this study was to compare the relative bioavailability of Venlafaxine MR Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Venlafaxine

Detailed Description

An open labeL balanced, randomized, two-treatment. two-period, two-sequence, single dose,crossover, evaluation of relative bioavailability of Venlafaxine 150 mg (as the HCl salt)MR capsules of Dr. Reddy's comparing with that of Effexor XR (containing Venlafaxine 150 mg (as the HCl salt)capsules of wyeth Laboratories, Philadelphia, PA, USA in healthy human subjects under fed conditions.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Hyderabad
    • Balanagar, Hyderabad, India, 500 037
      • Bioserve Clinical Research (P) Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must fulfill all of the following criteria to be considered for inclusion into this study:

• Subjects who will provide written informed consent.
• Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
• Having a Body mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2
• Subjects must be of normal health as determined by medical history and physical examination performed within 21days prior to the commencement of the study.
• Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.
• Have normal ECG, X-ray and vital signs.
• Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidence by written informed consent.

Exclusion Criteria:

• Subjects incapable of understanding the informed consent.

• Subjects who have:

  • Systolic blood pressure less than 90 mm of Hg and more than 140 .mm of Hg
  • Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.
  • Pulse rate below 50/min and above 100/min.
• History of hypersensitivity or idiosyncratic reaction to Venlafaxine or any other related drugs.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal .function.
• Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.
• Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and until the completion of the study.
• Subjects who have taken over the counter or prescribed medications for during the last 7 days from the date of study.
• Subjects who have taken enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical study
• History of any psychiatric illness, which may impair the ability to provide written, informed consent.
• Subjects with clinically significant abnormal values of laboratory parameters.
• Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 330 mL in the past 90 days before the date of start of study.
• Subjects with positive screen for drugs of abuse and alcohol.
• Any subject in whom Venlafaxine is contraindicated for medical reasons.
• Any subject with recent history of surgery
• A history of difficulty in donating blood.
• A positive test result for HIV antibody and/or syphilis
• A recent history of alcoholism (< 2 years) or of moderate (180 ml/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving Investigational Product.
• Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venlafaxine MR Capsules 150; Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited	Drug: Venlafaxine; Venlafaxine MR Capsules 150 mg; Other Names: Effexor XR
Active Comparator: Effexor XR 150 mg Capsules; Effexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA	Drug: Venlafaxine; Venlafaxine MR Capsules 150 mg; Other Names: Effexor XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under Curve (AUC)	predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Mohanlal Siva Prasad Sayana, Dr., Bioserve Clinical Research (P) Ltd

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: January 10, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Bioavailability; Venlafaxine; two way crossover
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; 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: 610/06