A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Valacyclovir hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir
hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®
caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in
healthy, adult, male, human subjects under fasting condition.
Clinical Details
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period,Two-sequence,Single-dose, Crossover, Bioequivalence Study Comparing Valacyclovir Hydrochloride Tablets 1 Gram of Ohm Laboratories Inc. (a Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With VALTREX® Caplets 1 Gram (Containing Valacyclovir Hydrochloride 1 Gram) of GlaxoSmithKline in Healthy, Adult, Male, Human Subjects Under Fasting Condition
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions
Detailed description:
Following an overnight fast of at least 10 hour, a single oral dose of valacyclovir
hydrochloride 1 gram of either test or reference investigational product was administered
during each period of the study, along with 240 mL of drinking water at ambient temperature
under low light condition and under supervision of trained study personnel. Both test and
reference products were administered to all the study subjects, one in each period (except
subject numbers 04, 21 and 27 who dropped out from the study).
During the course of the study, safety parameters assessed were vital signs, clinical
examination, medical history and clinical laboratory safety tests (hematology, biochemical
parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
throughout the study. Laboratory parameters of hematology and biochemistry (except blood
glucose and cholesterol) were repeated at the end of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance
Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of
the subjects performed within 21 days prior to the commencement of the study.
There were no deviations in this regard.
Exclusion Criteria:
- History of known hypersensitivity to valacyclovir, related drugs like acyclovir or to
any other drug.
- Any evidence of organ dysfunction or any clinically significant deviation from the
normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis
infection.
- Presence of values which were out of acceptable limits for hemoglobin, total white
blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- Presence of values which were out of acceptable limits for serum creatinine, blood
urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase
(ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum
cholesterol.
- Clinically abnormal chemical and microscopic examination of urine defined as presence
of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary,
neurological or hematological disease, diabetes or glaucoma.
- Inability to communicate well (i. e. language problem, poor mental development,
psychiatric illness or poor cerebral function) that might impair the ability to
provide, written informed consent.
- Regular smokers who smoked more than 10 cigarettes daily or have difficulty
abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more
than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer
or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the
duration of each study period.
- Use of any regular medication (OTC or prescription) with in 14 days or any drug
metabolizing enzyme modifying medications within 30 days prior to Day 1 of this
study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study
(except for the subjects who dropout/withdrawn from the previous study prior to
period I dosing).
- Subjects who, through completion of this study, would have donated and /or lost more
than 350 ml of blood in the past 3 months other than study participation.
There were no deviations in this regard.
Locations and Contacts
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited, Noida, Uttar Pradesh, India
Additional Information
Starting date: May 2009
Last updated: October 15, 2010
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