Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01512459
First received: January 10, 2012
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Venlafaxine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: May 2006
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venlafaxine MR Capsules 150
Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited
Drug: Venlafaxine
Venlafaxine MR Capsules 150 mg
Other Name: 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 Name: Effexor XR

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512459

Locations
India
Bioserve Clinical Research (P) Ltd
Balanagar, Hyderabad, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mohanlal Siva Prasad Sayana, Dr. Bioserve Clinical Research (P) Ltd
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01512459     History of Changes
Other Study ID Numbers: 610/06
Study First Received: January 10, 2012
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Venlafaxine
two way crossover

Additional relevant MeSH terms:
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014