HealthyPhase 1NCT03702855
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions
A Phase 1 study testing Tetrabenazine Tablets 25 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tetrabenazine Tablets 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to Dec 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and non pregnant female human subjects, age in the range of 18-45 years both inclusive.
- Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body weight > 50 kg.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs examination (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG.
- Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or use of grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
- No history of significant alcoholism.
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- No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
- Non-smokers, ex-smokers and moderate smokers were included. "Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months."
- Willing to use an acceptable, effective method of contraception.
- Subject must be literate, able to sign their name, and able to give voluntary written informed consent for the trial
- Able to read and understand the Informed Consent Form and Medication guide either in its original form (i.e. in English) or translated into a regional language
Who cannot join
- Subject is illiterate.
- Subjects with a history of depression or prior suicide attempts or ideation
- Known history of hypersensitivity to Tetrabenazine or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
- Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
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- History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
- Participation in a clinical drug study or bioequivalence study 90 days prior to Period-I dosing of the present study.
- History of malignancy or other serious diseases.
- Blood donation 90 days prior to period I dosing of the present study.
- Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- Found positive in urine test for drug abuse.
- History of problem in swallowing.
- Any contraindication to blood sampling.
- Found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
- Lactating women (currently breast feeding).
- Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- Use of hormonal contraceptives either oral or implants
Trial locations and contacts
1 site in 1 country.
India1 site
Accutest Research Laboratories (I) Pvt. Ltd.
Navi Mumbai, Maharashtra, 400709
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Four-period, Two-sequence, Single Dose, Crossover, Fully Replicated Oral Bioequivalence Study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India Comparing With XENAZINE® (Tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in Healthy, Adult, Human Subjects Under Fed Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
Read the detailed description
An open label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover, fully replicated oral bioequivalence study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India comparing with XENAZINE® (tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in healthy, adult, human subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Tetrabenazine Tablets 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetrabenazine Tablets 25 mgDrug
Also called Xenazine
| Study group | Role | What they receive |
|---|---|---|
| Tetrabenazine Tablets | Experimental | Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Tetrabenazine Tablets 25 mg |
| Xenazine | Active comparator | Xenazine Tablets 25 mg of Lundbeck Inc. Receives: Drug: Tetrabenazine Tablets 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve
Measured: Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.33, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 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 posted11 Oct 2018
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Vivekananda Murthi, MBBS, Principal investigator, Accutest Research Laboratories (I) Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702855
- Sponsor's protocol ID
- ARL/15/421
- Status last verified
- Mar 2016
- First submitted
- 9 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Four-period, Two-sequence, Single Dose, Crossover, Fully Replicated Oral Bioequivalence Study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India Comparing With XENAZINE® (Tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in Healthy, Adult, Human Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT03702855
- Acronym / sponsor ID
- ARL/15/421
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Oct 2018 (actual)
- 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 is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
Detailed description
An open label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover, fully replicated oral bioequivalence study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India comparing with XENAZINE® (tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetrabenazine Tablets | Experimental | Drug: Tetrabenazine Tablets 25 mgTetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited |
| Xenazine | Active comparator | Drug: Tetrabenazine Tablets 25 mgXenazine Tablets 25 mg of Lundbeck Inc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and non pregnant female human subjects, age in the range of 18-45 years both inclusive.
- Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body weight > 50 kg.
- Subjects with normal findings as determined by baseline history, physical examination and vital signs examination (blood pressure, pulse rate, respiration rate and axillary temperature).
- Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG.
- Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or use of grapefruit juice, any alcoholic products, the use of cigarettes and tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
Key exclusion criteria (18 listed)
- Subject is illiterate.
- Subjects with a history of depression or prior suicide attempts or ideation
- Known history of hypersensitivity to Tetrabenazine or related drugs.
- Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
- Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
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 |
|---|---|---|
| Tetrabenazine Tablets 25 mgAlso: Xenazine | Drug | Tetrabenazine Tablets, Xenazine |
Primary outcome
Area under curve
Time frame: Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.33, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 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 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Dr. Vivekananda Murthi, MBBS principal investigator
Accutest Research Laboratories (I) Pvt. 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 Tetrabenazine Tablets 25 mg 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 11 inclusion and 18 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 11 Oct 2018. 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 (time frame: Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.33, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 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 11 Oct 2018.