Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296723
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE November 20, 2014
Last Update Posted Date November 20, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
Official Title  ICMJE 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
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 Fed 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 Fed conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Valganciclovir Hydrochloride
Valganciclovir Hydrochloride Tablets 450 mg
Other Name: Valcyte
Study Arms  ICMJE
  • Experimental: Valganciclovir Hydrochloride Tablets 450 mg
    Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited
    Intervention: Drug: Valganciclovir Hydrochloride
  • Active Comparator: Valcyte
    Valcyte® 450 mg tablets of Genentech USA Inc., Sanfrancisco
    Intervention: Drug: Valganciclovir Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02296723
Other Study ID Numbers  ICMJE 570-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Pankaj Kumar Jha, MD Lambda Therapeutic Research Ltd.
PRS Account Dr. Reddy's Laboratories Limited
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP