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Trial record 16 of 737 for:    Area Under Curve AND Bioavailability

Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01512459
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE January 10, 2012
First Posted Date  ICMJE January 19, 2012
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Venlafaxine
Venlafaxine MR Capsules 150 mg
Other Name: Effexor XR
Study Arms  ICMJE
  • Experimental: Venlafaxine MR Capsules 150
    Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Venlafaxine
  • Active Comparator: Effexor XR 150 mg Capsules
    Effexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA
    Intervention: Drug: Venlafaxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2012)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512459
Other Study ID Numbers  ICMJE 610/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohanlal Siva Prasad Sayana, Dr. Bioserve Clinical Research (P) Ltd
PRS Account Dr. Reddy's Laboratories Limited
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP