Healthy
Conditions
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.
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 Fasting conditions.
Interventions
Valganciclovir Hydrochloride Tablets 450 mg
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Outcome results
None listed