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Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03696329
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief 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 fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Tetrabenazine Tablets 25 mg Phase 1

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 fasting conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Fasting Conditions.
Actual Study Start Date : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tetrabenazine Tablets
Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited
Drug: Tetrabenazine Tablets 25 mg
Other Name: Xenazine

Active Comparator: Xenazine
Xenazine Tablets 25 mg of Lundbeck Inc.
Drug: Tetrabenazine Tablets 25 mg
Other Name: Xenazine

Primary Outcome Measures :
  1. Area under curve [ Time Frame: Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00 hours post dose. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male and non pregnant female human subjects, age in the range of 18-45 years both inclusive.
  2. Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body weight > 50 kg.
  3. Subjects with normal findings as determined by baseline history, physical examination and vital signs examination (blood pressure, pulse rate, respiration rate and axillary temperature).
  4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG.
  5. 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.
  6. No history of significant alcoholism.
  7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 6 months.
  8. 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."
  9. Willing to use an acceptable, effective method of contraception.
  10. Subject must be literate, able to sign their name, and able to give voluntary written informed consent for the trial
  11. 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

Exclusion Criteria:

  1. Subject is illiterate.
  2. Subjects with a history of depression or prior suicide attempts or ideation
  3. Known history of hypersensitivity to Tetrabenazine or related drugs.
  4. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
  5. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of Investigational Product.
  6. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
  7. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
  8. Participation in a clinical drug study or bioequivalence study 90 days prior to Period-I dosing of the present study.
  9. History of malignancy or other serious diseases.
  10. Blood donation 90 days prior to period I dosing of the present study.
  11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
  12. Found positive in urine test for drug abuse.
  13. History of problem in swallowing.
  14. Any contraindication to blood sampling.
  15. Found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
  16. Lactating women (currently breast feeding).
  17. 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.
  18. Use of hormonal contraceptives either oral or implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03696329

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Accutest Research Laboratories (I) Pvt. Ltd.
Navi Mumbai, Maharashtra, India, 400709
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Dr. Vivekananda Murthi, MBBS Accutest Research Laboratories (I) Pvt. Ltd.

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Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT03696329    
Other Study ID Numbers: ARL/15/420
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs