Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions

An open label, balanced, randomized, two-treatment, two-sequence two-period, single-dose, crossover comparative bioavailability study of 1000 mg Valacyclovir Hydrochloride Tablets of Dr. Reddy's Laboratories Ltd., India and valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline in healthy, adult human subjects under fasting conditions

Inclusion criteria

The subjects were selected for study participation, based on the following criteria:

• Human subjects aged between 18 and 45 years (including both).
• Subjects' weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (PIA view).
• Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Have negative alcohol breath test.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion criteria

The subjects were excluded from the study, based on the following criteria:

• Hypersensitivity to Valacyclovir Hydrochloride or related drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes or beedi' s/day).
• History or presence of significant asthma, urticaria or other allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
• History or presence of cancer.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
• 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°F or more than 98.6°F.
• Respiratory rate less than 12/minute or more than 20/minute
• Subjects who have used any prescription medication, within 14 days of period 01 dosing or OTC medication within 14 days of period 01 dosing.
• Major illness during 3 months before screening.
• Participation in a drug research study within past 3 months.
• Donation of blood in the past 3 months before screening.
• Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to period 01 dosing.
• Subjects who have consumed food or beverages containing grapefruit or pomelo within 14 days prior to period 01 dosing.
• Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
• Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.