bioequivalence study of torrent pharmaceutical limited's venlafaxine hydrochloride er capsules under fed conditions

Conditions: Healthy

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


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.