Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

Condition(s) targeted: Healthy

Intervention: Valganciclovir Hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Dr. Pankaj Kumar Jha, MD, Principal Investigator, Affiliation: Lambda Therapeutic Research Ltd

This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed conditions.

Official title: Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under curve (AUC)

Detailed description: Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fed conditions.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy, adult, human volunteers between 18 to 55 years of age (both inclusive)

living in and around Ahmedabad city or western part of lndia

- Having a Body Mass Index (BMD between 18. 5 - 24. 9 (both inclusive), calculated as

weight in kg / height in meter2

- Not having any significant disease in medical history or clinically significant

abnormal findings during screening, medical history, physical examination, laboratory evaluations, L2- lead ECG and X-ray chest (postero-anterior view) recordings

- Able to understand and comply with the study procedures, in the opinion of the

principal investigator

- Able to give voluntary written informed consent for participation in the trial

- In case of Male subjects:

- Willing to practice an acceptable barrier contraception method of birth control

for the entire duration of the study and at least for 90 days after the last dose administration, and in case of an accidental pregnancy of their spouse should be willing to abort the pregnancy Or

- Surgically sterile who have undergone vasectomy

- In case of female subjects:

- Surgically sterilized (Bilateral tubal ligation, bilateral oophorectomy, or

hysterectomy) at least 6 months prior to study participation Or

- If of child bearing potential is willing to use a suitable and effective double

barrier contraceptive method or intra uterine device of birth control or abstinence for the entire during of the study and at least 90 days after the last study drug administration and in case of an accidental pregnancy should be willing to abort the pregnancy Or

- Postmenopausal women: Women who are postmenopausal for at least 1 year having

Follicle stimulating Hormone (FSH) level and serum estradiol level (without hormone replacement therapy) within specified limit suggestive of menopausal state, having normal bilateral mammogram and normal ultrasound abdomen and pelvis And

- Pregnancy test must be negative

Exclusion Criteria:

- Known hypersensitivity or idiosyncratic reaction to Valganciclovir and/or ganciclovir

or any of the excipients or any related drug

- History or presence of any disease or condition which might compromise the

haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system

- Ingestion of a medicine at any time within 14 days before dosing in Period I In any

such case subject selection will be at the discretion of the Principal Investigator.

- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp

or NSAID induced urticaria

- A recent history of harmful use of alcohol(less than 2 years), i,e. alcohol

consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40o/o distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine

- Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from

smoking during the study

- The presence of clinically significant abnormal laboratory values during screening

- Use of any recreational drugs or history of drug addiction or testing positive in

prestudy drug scans

- History or presence of psychiatric disorders

- A history of difficulty in donating blood

- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal

product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study Note: In case the blood loss is < 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study

- A positive hepatitis screen including hepatitis B surface antigen and HCV (Hepatitis

C Virus) antibodies

- A positive test result for HIV antibody

- An unusual diet, for whatever reason (e. g. low-sodium), for four weeks prior to

receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator

- Consumption of grape fruit or grape fruit products within 48 hours prior to dosing.

- Nursing mothers (females)

Lambda Therapeutic Research Ltd, Ahmedabad, Gujrat 380 061, India

Starting date: July 2011
Last updated: November 19, 2014