Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions

NCT ID: NCT01512459

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venlafaxine MR Capsules 150

Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Venlafaxine

Intervention Type: DRUG

Venlafaxine MR Capsules 150 mg

Effexor XR 150 mg Capsules

Effexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA

Group Type: ACTIVE_COMPARATOR

Venlafaxine

Intervention Type: DRUG

Venlafaxine MR Capsules 150 mg

Interventions

Venlafaxine

Venlafaxine MR Capsules 150 mg

Intervention Type: DRUG

Other Intervention Names

Effexor XR

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohanlal Siva Prasad Sayana, Dr.

Role: PRINCIPAL_INVESTIGATOR

Bioserve Clinical Research (P) Ltd

Locations

Bioserve Clinical Research (P) Ltd

Bālānagar, Hyderabad, India

Countries

India

Other Identifiers

610/06

Identifier Type: -

Identifier Source: org_study_id