Back to resultsBioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India)
Sponsored by
About this trial
This is an interventional trial for Healthy
Eligibility Criteria
Inclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
- Sex: male.
- Age: 18 - 45 years. .
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute.
- Oral temperature less than 95°P or more than 98.6°P.
- Respiratory rate less than 12/minute or more than 20/minute
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- History of alcohol or drug abuse
- Positive breath alcohol test
- Recent history of kidney or liver dysfunction.
- History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of heart failure.
- HIV, HCV, HBsAg positive volunteers.
- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - -Cocaine positive volunteers based on urine test.
- Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any study drug in the period 0 to 3 months before entry to the study.
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- History of pre-existing bleeding disorder.
- Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
- Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Sites / Locations
Outcomes
Primary Outcome Measures
Bioequivalence based on Composite of Pharmacokinetics
Bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
Secondary Outcome Measures
Full Information
NCT ID
NCT01418625
First Posted
August 10, 2011
Last Updated
August 16, 2011
Sponsor
Torrent Pharmaceuticals Limited
1. Study Identification
Unique Protocol Identification Number
NCT01418625
Brief Title
Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
Official Title
An Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test Formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg Capsule (Reference Formulation, Wyeth Pharmaceuticals Inc., USA) Administered as the Contents of Capsule Sprinkled Over Apple Sauce in Healthy Volunteers Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Torrent Pharmaceuticals Limited
4. Oversight
5. Study Description
Brief Summary
Objective:
The Bioequivalence studies were performed to compare the rate and extent of release of the drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR® (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc., USA.
Study Design:
Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India)
Primary Outcome Measure Information:
Title
Bioequivalence based on Composite of Pharmacokinetics
Description
Bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
Inclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
Sex: male.
Age: 18 - 45 years. .
Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
Healthy and willing to participate in the study.
Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
Non-smokers or smoker who smokes less than 10 cigarettes per day
Exclusion Criteria:
The volunteers were excluded from the study based on the following criteria:
Clinically relevant abnormalities in the results of the laboratory screening evaluation.
Clinically significant abnormal ECG or Chest X-ray.
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
Pulse rate less than 50/minute or more than 100/minute.
Oral temperature less than 95°P or more than 98.6°P.
Respiratory rate less than 12/minute or more than 20/minute
History of allergy to the test drug or any drug chemically similar to the drug under investigation.
History of alcohol or drug abuse
Positive breath alcohol test
Recent history of kidney or liver dysfunction.
History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
Volunteers suffering from any chronic illness such as arthritis, asthma etc.
History of heart failure.
HIV, HCV, HBsAg positive volunteers.
Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - -Cocaine positive volunteers based on urine test.
Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
Administration of any study drug in the period 0 to 3 months before entry to the study.
History of significant blood loss due to any reason, including blood donation in the past 3 months.
History of pre-existing bleeding disorder.
Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
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