HealthyPhase 1NCT02297854
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
A Phase 1 study testing Valganciclovir Hydrochloride in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valganciclovir Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2011to Aug 2011
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, human volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5-24.9 (both inclusive), calculated as weight in kg / height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of Male subjects:
Show all 13Show fewer
- Willing to practice an acceptable barrier contraception method of birth control for the entire duration of the study and at least for 90 days after the last dose administration, and in case of an accidental pregnancy of their spouse should be willing to abort the pregnancy. Or
- Surgically sterile who have undergone vasectomy.
- In case of female subjects:
- Surgically sterilized (Bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 months prior to study participation; Or
- If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device of birth control or abstinence for the entire during of the study and at least 90 days after the last study drug administration and in case of an accidental pregnancy should be willing to abort the pregnancy. Or
- Postmenopausal women: Women who are postmenopausal for at least 1 year having Follicle stimulating Hormone (FSH) level and serum estradiol level (without hormone replacement therapy) within specified limit suggestive of menopausal state, having normal bilateral mammogram and normal ultrasound abdomen and pelvis. And
- Pregnancy test must be negative. No female volunteers were enrolled in the trial.
Who cannot join
- The exclusion criteria as per the protocol were as follows:
- Known hypersensitivity or idiosyncratic reaction to Valganciclovir and/or ganciclovir or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of harmful use of alcohol(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
Show all 17Show fewer
- Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study
- The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in prestudy drug scans.
- History or presence of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood donation or last sample of the previous study.
- A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
- A positive test result for HIV antibody.
- An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine. In any such case subject selection will be at the discretion of the Principal Investigator.
- Consumption of grape fruit or grape fruit products within 48 hours prior to dosing.
- Nursing mothers (females). No female volunteers were enrolled in the trial.Nursing mothers (females).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting conditions.
Read the detailed description
Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fasting conditions.
- Conditions
- Healthy
- Being tested
- Valganciclovir Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valganciclovir HydrochlorideDrug
Also called Valcyte
Valganciclovir Hydrochloride Tablets 450 mg
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir Hydrochloride Tablets 450 mg | Experimental | Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited Receives: Drug: Valganciclovir Hydrochloride |
| Valcyte | Active comparator | Valcyte® 450 mg tablets of Genentech USA Inc., San Francisco Receives: Drug: Valganciclovir Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: 0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionAug 2011
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Aplesh kumar Patel, MD, Principal investigator, Lambda Therapeutic Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297854
- Sponsor's protocol ID
- 569-10
- Status last verified
- Sep 2011
- First submitted
- 19 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Cross Over, Single Dose, Oral Bioequivalence Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
- ClinicalTrials.gov ID
- NCT02297854
- Acronym / sponsor ID
- 569-10
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Nov 2014 (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.
This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting conditions.
Detailed description
Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir Hydrochloride Tablets 450 mg | Experimental | Drug: Valganciclovir HydrochlorideValganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited |
| Valcyte | Active comparator | Drug: Valganciclovir HydrochlorideValcyte® 450 mg tablets of Genentech USA Inc., San Francisco |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy, adult, human volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5-24.9 (both inclusive), calculated as weight in kg / height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings.
- Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- Able to give voluntary written informed consent for participation in the trial.
Key exclusion criteria (17 listed)
- Known hypersensitivity or idiosyncratic reaction to Valganciclovir and/or ganciclovir or any of the excipients or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- A recent history of harmful use of alcohol(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
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 |
|---|---|---|
| Valganciclovir HydrochlorideAlso: ValcyteValganciclovir Hydrochloride Tablets 450 mg | Drug | Valcyte, Valganciclovir Hydrochloride Tablets 450 mg |
Primary outcome
Area under curve (AUC)
Time frame: 0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose
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 21 Nov 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Dr. Aplesh kumar Patel, MD principal investigator
Lambda Therapeutic Research 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 Valganciclovir Hydrochloride in people with Healthy, run by Dr. Reddy's 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 13 inclusion and 17 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 Nov 2014. 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.
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?
Area under curve (AUC) (time frame: 0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose). 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 21 Nov 2014.