Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

NCT02297854 | Completed Phase 1 DMC

• 1 other identifier: 569-10
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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 Fasting conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  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

Study Arms (2)

Valganciclovir Hydrochloride Tablets 450 mg

EXPERIMENTAL

Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited

Drug: Valganciclovir Hydrochloride

Valcyte

ACTIVE COMPARATOR

Valcyte® 450 mg tablets of Genentech USA Inc., San Francisco

Drug: Valganciclovir Hydrochloride

Interventions

Valganciclovir Hydrochloride DRUG

Valganciclovir Hydrochloride Tablets 450 mg

Also known as: Valcyte

Valcyte; Valganciclovir Hydrochloride Tablets 450 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd

Ahmedabad, Gujarat, 380 061, India

Location

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Aplesh kumar Patel, MD

  Lambda Therapeutic Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: July 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 21, 2014

Record last verified: 2011-09

Locations

IN (1)