A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition

NCT01222910 | Completed

• 1 other identifier: 217_VALAC_09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Valacyclovir hydrochloride fasting study

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions

Study Arms (2)

Test

EXPERIMENTAL

Valacyclovir hydrochloride tablets 1 gm of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)

Drug: Valacyclovir hydrochloride

Reference

ACTIVE COMPARATOR

VALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709

Drug: Valacyclovir hydrochloride

Interventions

Valacyclovir hydrochloride DRUG

Reference; Test

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, India

Location

Related Links

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MeSH Terms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: May 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 18, 2010

Record last verified: 2010-10

Locations

IN (1)