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Trial record 2 of 103 for:    Valcyte

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

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ClinicalTrials.gov Identifier: NCT02297854
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Valganciclovir Hydrochloride Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Fasting Condition
Study Start Date : July 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

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Arm Intervention/treatment
Experimental: Valganciclovir Hydrochloride Tablets 450 mg
Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited
Drug: Valganciclovir Hydrochloride
Valganciclovir Hydrochloride Tablets 450 mg
Other Name: Valcyte

Active Comparator: Valcyte
Valcyte® 450 mg tablets of Genentech USA Inc., San Francisco
Drug: Valganciclovir Hydrochloride
Valganciclovir Hydrochloride Tablets 450 mg
Other Name: Valcyte




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297854


Locations
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India
Lambda Therapeutic Research Ltd
Ahmedabad, Gujrat, India, 380 061
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. Aplesh kumar Patel, MD Lambda Therapeutic Research Ltd.

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02297854     History of Changes
Other Study ID Numbers: 569-10
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: September 2011
Additional relevant MeSH terms:
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Valganciclovir
Antiviral Agents
Anti-Infective Agents