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Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions

Information source: Torrent Pharmaceuticals Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Torrent Pharmaceuticals Limited

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

Clinical Details

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 design: N/A

Primary outcome: Bioequivalence based on Composite of Pharmacokinetics

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

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Additional Information


Last updated: August 16, 2011

Page last updated: August 23, 2015

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