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Completed

NCT Number: NCT03914534

Bioequivalence Study of Sodium Divalproate Tablets 500 mg

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidad de la Sabana

Chía, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproic Acid 500 MG

Drug

Administration of 500 mg of Valproic Acid

Valcote 500 mg

Drug

Administration of 500 mg of Valproic Acid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tecnoquimicas

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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