Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition

NCT01136538 | Completed Phase 1 DMC

• 1 other identifier: 07-VIN-028
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to

1. 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 fed conditions.
2. 2.monitor the adverse events and ensure the safety of subjects.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Valacyclovir Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  4 months

Study Arms (2)

Valacyclovir Hydrochloride

EXPERIMENTAL

Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited

Drug: Valacyclovir Hydrochloride

Valtrex (R)

ACTIVE COMPARATOR

Valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline

Drug: Valacyclovir Hydrochloride

Interventions

Valacyclovir Hydrochloride DRUG

Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited

Also known as: Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm

Valacyclovir Hydrochloride; Valtrex (R)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects were selected for study participation, based on the following criteria:
• Human subjects aged between 18 and 45 years (including both).
• 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.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (PIA view).
• Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Have negative alcohol breath test.
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.

You may not qualify if:

• The subjects were excluded from the study, based on the following criteria:
• Hypersensitivity to Valacyclovir Hydrochloride or related drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes or beedi' s/day).
• History or presence of significant asthma, urticaria or other allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
• History or presence of cancer.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
• Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50/minute or more than 100/minute.
• Oral temperature less than 95°F or more than 98.6°F.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Veeda clinical research Pvt. Ltd., India

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. Dharmesh Domadia, MD

  Veeda clinical research Pvt. Ltd., India

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: February 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

IN (1)