A Bioequivalence Study with Valacyclovir in Healthy Japanese Subjects

• Research type

  Research Study

• Full title

  An Open Label, Laboratory Blind, Single Dose, Two Period Crossover Study to Compare the Bioavailability of Valacyclovir Hydrochloride 500 mg Film-Coated Tablets of Actavis Group PTC ehf, Iceland and Valtrex™ (Valacyclovir Hydrochloride) 500 mg Film Coated Tablets of GlaxoSmithKline From the Japanese Market under Fasting Conditions in Healthy Japanese Volunteers

• IRAS ID

  101586

• Contact name

  Muna Albayaty

• Sponsor organisation

  Actavis Group PTC ehf.

• Eudract number

  2012-000761-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study will be performed at the PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow, London. The Test product is similar to the Reference product that is already marketed as Valtrex©. Both products contain valacyclovir. Valacyclovir is used in the treatment of viral infections caused by the herpes zoster, herpes simplex genitalis, and herpes labialis viruses. The main purpose of the study is to investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. The study will also investigate how safe the study drug is and how well it is tolerated after dosing. This study will recruit healthy, non-smoking Japanese males and females of 20 years or older. A total of up to 28 participants will take part in the study. The study consists of a Screening Visit, 2 Treatment Periods and a Follow-up Visit. Participants will be dosed on Day 1 of each Treatment Period and have assessments performed until 24 hours after dosing and will be released from the Unit on Day 2. Treatment Periods will be separated by 5 days (wash-out period). Participants will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate, respiratory rate and body temperature measurements will be taken, different kinds of urine and blood safety tests will be performed, blood samples for measurement of the concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0122

• Date of REC Opinion

  19 Mar 2012

• REC opinion

  Favourable Opinion