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Bioequivalence Study of Sodium Divalproate Tablets 500 mg

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ClinicalTrials.gov Identifier: NCT03914534
Recruitment Status : Completed
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tecnoquimicas

Brief Summary:
The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

Condition or disease Intervention/treatment Phase
Healthy Drug: Valproic Acid 500 MG Drug: Valcote 500 mg Phase 4

Detailed Description:
This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Formulation of Valproic Acid
Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2
Drug: Valproic Acid 500 MG
Administration of 500 mg of Valproic Acid

Active Comparator: Reference Formulation of Valproic Acid
Valcote tablets 500 mg Single dose administered in dosing period 1 or 2
Drug: Valcote 500 mg
Administration of 500 mg of Valproic Acid




Primary Outcome Measures :
  1. (AUC) Area Under the Curve 0-48 [ Time Frame: From 0 to 48 hours ]
    0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours

  2. Cmax [ Time Frame: From 0 to 48 hours ]
    0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours


Secondary Outcome Measures :
  1. Tmax [ Time Frame: From 0 to 48 hours ]
    0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours

  2. Kel [ Time Frame: From 0 to 48 hours ]
    0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and Women from 18 to 50 years old
  • Diagnosed as healthy after a clinical examination
  • BMI from 18 to 30 kg/m2
  • Not smoking for at least 3 months
  • To sign the informed consent
  • Not having participated in a similar study for at least 4 months

Exclusion Criteria:

  • Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
  • Hematologic disorders, specially anemia and polycythemia
  • Permanent or temporal pharmacological therapy, prescribed or not
  • Smoking for the last 3 months
  • Alcohol drinker more than once a week
  • Drug abuse
  • Drug hypersensitivity
  • Angioedema or anaphylaxis history
  • Pregnancy or breast-feeding
  • HIV o Hepatitis B diagnosed
  • Blood donor in the past 30 days

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 ClinicalTrials.gov identifier (NCT number): NCT03914534


Locations
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Colombia
Universidad de la Sabana
Chía, Colombia
Sponsors and Collaborators
Tecnoquimicas

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Responsible Party: Tecnoquimicas
ClinicalTrials.gov Identifier: NCT03914534     History of Changes
Other Study ID Numbers: Versión 1- BIO 088
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Valproic Acid
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs