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HealthyPhase 1NCT01149460

Valacyclovir 1000 mg Tablet Under Fed Conditions

A Phase 1 study testing Valacyclovir in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed 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
36 participants
Where
1 siteCanada
Study dates
Sep 2004to Sep 2004
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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.
  • BMI less than 19.0 or greater than or equal to 30.0 kg/m2.
  • History of significant alcohol abuse 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.
  • History of drug abuse or use of illegal drugs: 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 urine 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.

Canada1 site

  • Anapharm Inc.

    Sainte-Foy, Quebec, G1V 2K8

Other trials in Canada

About this study

Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Valacyclovir 1000 mg Tablet and Valtrex Administered as 1 x 1000 mg Tablet in Healthy Subjects Under Fed Conditions

The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed 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

    Test 1000 mg Tablet

  • ValacyclovirDrug

    Also called Valtrex

    Reference Listed Valacyclovir 1000 mg Tablet

Study groups in NCT01149460
Study groupRoleWhat they receive
ValacyclovirExperimentalTest 1000 mg Tablet
Receives: Drug: Valacyclovir
ValtrexActive comparatorReference Listed Valacyclovir 1000 mg Tablet
Receives: Drug: Valacyclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir

    Bioequivalence based on Cmax

    Measured: Blood samples collected over 12 hour period

  2. AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir

    Bioequivalence based on AUC0-t

    Measured: Blood samples collected over 12 hour period

  3. AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir

    Bioequivalence based on AUC0-inf

    Measured: Blood samples collected over 12 hour period

Secondary outcomes (3)

  1. Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir

    Measured: Blood samples collected over 24 hour period

  2. AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir

    Measured: Blood samples collected over 24 hour period

  3. AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir

    Measured: Blood samples collected over 24 hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2010 (estimated)
  2. Study startSep 2004
  3. Primary completionSep 2004
  4. Study completionSep 2004

Resources

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
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01149460
Sponsor's protocol ID
40280
Status last verified
Aug 2024
First submitted
21 Jun 2010
Last updated
21 Aug 2024
Data monitoring committee
No

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 Canada.

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 2 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 21 Aug 2024. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 14 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) - Valacyclovir (time frame: Blood samples collected over 12 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?

On the ClinicalTrials.gov record for NCT01149460.

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 21 Aug 2024.

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