Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions

NCT01512459 | Completed Phase 1 DMC

• 1 other identifier: 610/06
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; Venlafaxine; two way crossover

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Venlafaxine MR Capsules 150

EXPERIMENTAL

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

Drug: Venlafaxine

Effexor XR 150 mg Capsules

ACTIVE COMPARATOR

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

Drug: Venlafaxine

Interventions

Venlafaxine DRUG

Venlafaxine MR Capsules 150 mg

Also known as: Effexor XR

Effexor XR 150 mg Capsules; Venlafaxine MR Capsules 150

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research (P) Ltd

Bālānagar, Hyderabad, 500 037, India

Location

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Mohanlal Siva Prasad Sayana, Dr.

  Bioserve Clinical Research (P) Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: May 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 19, 2012

Record last verified: 2012-01

Locations

IN (1)