HealthyNCT01222910
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fasting Condition
A study testing Valacyclovir hydrochloride in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valacyclovir hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- May 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- There were no deviations in this regard.
Who cannot join
- History of known hypersensitivity to valacyclovir, related drugs like acyclovir or to any other drug.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were out of acceptable limits for hemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- Presence of values which were out of acceptable limits for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
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- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.
- Regular smokers who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
- Use of any regular medication (OTC or prescription) with in 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study (except for the subjects who dropout/withdrawn from the previous study prior to period I dosing).
- Subjects who, through completion of this study, would have donated and /or lost more than 350 ml of blood in the past 3 months other than study participation.
- There were no deviations in this regard.
Trial locations and contacts
1 site in 1 country.
India1 site
Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited
Noida, Uttar Pradesh
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period,Two-sequence,Single-dose, Crossover, Bioequivalence Study Comparing Valacyclovir Hydrochloride Tablets 1 Gram of Ohm Laboratories Inc. (a Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With VALTREX® Caplets 1 Gram (Containing Valacyclovir Hydrochloride 1 Gram) of GlaxoSmithKline in Healthy, Adult, Male, Human Subjects Under Fasting Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX® caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy, adult, male, human subjects under fasting condition.
Read the detailed description
Following an overnight fast of at least 10 hour, a single oral dose of valacyclovir hydrochloride 1 gram of either test or reference investigational product was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period (except subject numbers 04, 21 and 27 who dropped out from the study).
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
- Conditions
- Healthy
- Being tested
- Valacyclovir hydrochloride
- Keywords
- Valacyclovir hydrochloride fasting study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Valacyclovir hydrochloride tablets 1 gm of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.) Receives: Drug: Valacyclovir hydrochloride |
| Reference | Active comparator | VALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709 Receives: Drug: Valacyclovir hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222910
- Sponsor's protocol ID
- 217_VALAC_09
- Status last verified
- Oct 2010
- First submitted
- 15 Oct 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period,Two-sequence,Single-dose, Crossover, Bioequivalence Study Comparing Valacyclovir Hydrochloride Tablets 1 Gram of Ohm Laboratories Inc. (a Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With VALTREX® Caplets 1 Gram (Containing Valacyclovir Hydrochloride 1 Gram) of GlaxoSmithKline in Healthy, Adult, Male, Human Subjects Under Fasting Condition
- ClinicalTrials.gov ID
- NCT01222910
- Acronym / sponsor ID
- 217_VALAC_09
- Conditions
- Healthy
- Keywords
- Valacyclovir hydrochloride fasting study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing valacyclovir hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX® caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy, adult, male, human subjects under fasting condition.
Detailed description
Following an overnight fast of at least 10 hour, a single oral dose of valacyclovir hydrochloride 1 gram of either test or reference investigational product was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period (except subject numbers 04, 21 and 27 who dropped out from the study).
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Valacyclovir hydrochlorideValacyclovir hydrochloride tablets 1 gm of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.) |
| Reference | Active comparator | Drug: Valacyclovir hydrochlorideVALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- There were no deviations in this regard.
Key exclusion criteria (16 listed)
- History of known hypersensitivity to valacyclovir, related drugs like acyclovir or to any other drug.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were out of acceptable limits for hemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir hydrochloride | Drug | Reference, Test |
Primary outcome
Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valacyclovir hydrochloride in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2010.