Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02297854
• Date of registration: 19/11/2014
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
• Scientific 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 Fasting Condition
• Date of first enrolment: July 2011
• Target sample size: 83
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02297854
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Dr. Aplesh kumar Patel, MD
• Affiliation: Lambda Therapeutic Research Ltd

Key inclusion & exclusion 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 India.

- Having a Body Mass Index (BMI) 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, 12- 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. No female volunteers were enrolled in the trial.

Exclusion Criteria :

The exclusion criteria as per the protocol were as follows:

- 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 40% 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 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). No female volunteers were enrolled in the trial.Nursing
mothers (females).



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Valganciclovir Hydrochloride

Primary Outcome(s)

Area under curve (AUC) [Time Frame: 0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose]

Secondary ID(s)

569-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors