HealthyPhase 1NCT01149499
Valacyclovir 1000 mg Tablet Under Fasting Conditions
A Phase 1 study testing Valacyclovir in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The objective of this study is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valacyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2005
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smokers, 18 years of age and older.
- Capable of consent
- BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
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- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol or drug abuse within one year prior to the screening visit
- Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40% alcohol]) or positive urine drug screen at screening.
- Use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to heparin, valacyclovir, acyclovir, or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medication.
- Use of an investigational drug or participation in an investigation study within 30 days prior to the administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 90 days preceding drug administration.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, could contraindicate the subjects participation in this study.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- 50 mL to 300 mL of whole blood within 30 days,
- 301 mL to 500 mL of whole blood within 45 days, or
- more than 500 mL of whole blood within 56 days prior to drug administration.
- Intolerance to venipunctures.
- Clinically significant history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Unable to understand or unwilling to sign the Informed Consent Form.
- Breast-feeding.
- Positive serum pregnancy test at screening.
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception:
- Intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration),
- Condom or diaphragm + spermicide
Trial locations and contacts
1 site in 1 country.
United States1 site
PRACS Institute, Ltd.
East Grand Forks, Minnesota, 56721
About this study
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Valacyclovir 1000 mg Tablet and Valtrex Following a 1 x 1000 mg Dose in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions.
- Conditions
- Healthy
- Being tested
- Valacyclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValacyclovirDrug
1000 mg Tablet
ValacyclovirDrug
Also called Valtrex
1000 mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| Valacyclovir | Experimental | Test 1000 mg Valacyclovir Tablet Receives: Drug: Valacyclovir |
| Valtrex | Active comparator | Reference Listed 1000 mg Valtrex Tablet Receives: Drug: Valacyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum observed concentration of drug substance in plasma)
Bioequivalence based on Cmax
Measured: Blood samples collected over 16 hour period
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 16 hour period
AUC0-inf (area under the concentration-time curve from time zero to infinity)
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 16 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJan 2005
- Primary completionJan 2005
- Study completionJan 2005
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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D Carlson, Pharm. D, Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149499
- Sponsor's protocol ID
- R04-1770
- Status last verified
- Jun 2010
- First submitted
- 21 Jun 2010
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-Way Crossover, Bioequivalence Study of Valacyclovir 1000 mg Tablet and Valtrex Following a 1 x 1000 mg Dose in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01149499
- Acronym / sponsor ID
- R04-1770
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 23 Jun 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 objective of this study is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valacyclovir | Experimental | Drug: ValacyclovirTest 1000 mg Valacyclovir Tablet |
| Valtrex | Active comparator | Drug: ValacyclovirReference Listed 1000 mg Valtrex Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, non-smokers, 18 years of age and older.
- Capable of consent
- BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2
Key exclusion criteria (32 listed)
- Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
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 |
|---|---|---|
| Valacyclovir1000 mg Tablet | Drug | Valacyclovir |
| ValacyclovirAlso: Valtrex1000 mg Tablet | Drug | Valtrex |
Primary outcome
Cmax (maximum observed concentration of drug substance in plasma)
Time frame: Blood samples collected over 16 hour period
Bioequivalence based on Cmax
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Time frame: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-t
AUC0-inf (area under the concentration-time curve from time zero to infinity)
Time frame: Blood samples collected over 16 hour period
Bioequivalence based on AUC0-inf
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 23 Jun 2010.
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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.
James D Carlson, Pharm. D principal investigator
PRACS Institute, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valacyclovir in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
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 3 inclusion and 32 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 23 Jun 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cmax (maximum observed concentration of drug substance in plasma) (time frame: Blood samples collected over 16 hour period). The study lists 3 primary outcomes in all. 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 23 Jun 2010.