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Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01136525
First received: June 2, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to

  1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of GlaxoSmithkline, in healthy, adult human subjects under fasting conditions.
  2. monitor the adverse events and ensure the safety of subjects.

Condition Intervention Phase
Healthy
Drug: Valacyclovir Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Balanced, Randomized, Two Treatment, Two-sequence, Two-period, Single-dose Crossover Comparative Bioavailability Study of 1000 mg Valacyclovir HCl Tablets of Dr. Reddys's and Valtrex (R) 1 gm Caplets of GlaxoSmithkline in Healthy Volunteers Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Drug: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Other Name: Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm
Active Comparator: Valtrex (R)
Valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline
Drug: Valacyclovir Hydrochloride
Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Other Name: Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm

Detailed Description:

An open label, balanced, randomized, two-treatment, two-sequence two-period, single-dose, crossover comparative bioavailability study of 1000 mg Valacyclovir Hydrochloride Tablets of Dr. Reddy's Laboratories Ltd., India and valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline in healthy, adult human subjects under fasting conditions

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The subjects were selected for study participation, based on the following criteria:

  1. Human subjects aged between 18 and 45 years (including both).
  2. Subjects' weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
  4. Subjects having normal 12-lead electrocardiogram (ECG).
  5. Subjects having normal chest X-Ray (PIA view).
  6. Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  7. Have negative alcohol breath test.
  8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

The subjects were excluded from the study, based on the following criteria:

  1. Hypersensitivity to Valacyclovir Hydrochloride or related drugs.
  2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  3. History or presence of significant alcoholism or drug abuse in the past one year.
  4. History or presence of significant smoking (more than 10 cigarettes or beedi' s/day).
  5. History or presence of significant asthma, urticaria or other allergic reactions.
  6. History or presence of significant gastric and/or duodenal ulceration.
  7. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
  8. History or presence of cancer.
  9. Difficulty with donating blood.
  10. Difficulty in swallowing solids like tablets or capsules.
  11. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
  12. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  13. Pulse rate less than 50/minute or more than 100/minute.
  14. Oral temperature less than 95°F or more than 98.6°F.
  15. Respiratory rate less than 12/minute or more than 20/minute
  16. Subjects who have used any prescription medication, within 14 days of period 01 dosing or OTC medication within 14 days of period 01 dosing.
  17. Major illness during 3 months before screening.
  18. Participation in a drug research study within past 3 months.
  19. Donation of blood in the past 3 months before screening.
  20. Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to period 01 dosing.
  21. Subjects who have consumed food or beverages containing grapefruit or pomelo within 14 days prior to period 01 dosing.
  22. Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
  23. Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136525

Locations
India
Veeda clinical research Pvt. Ltd., India
Ahmedabad, Gujrat, India, 380 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Dharmesh Domadia, MD Veeda clinical research Pvt. Ltd., India
  More Information

No publications provided

Responsible Party: Mr. Indu Bhushan/Senior Director, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01136525     History of Changes
Other Study ID Numbers: 07-VIN-027
Study First Received: June 2, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Valacyclovir Hydrochloride

Additional relevant MeSH terms:
Acyclovir
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014