Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Healthy Clinical Trial

Official title:

Bioequivalence Study of Sodium Divalproate Tablets 500 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914534
• Other study ID #: Versión 1- BIO 088
• Status: Completed
• Phase: Phase 4
• Start date: April 17, 2017
• Est. completion date: February 12, 2019

Study information

• Verified date: April 2019
• Source: Tecnoquimicas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 12, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Valproic Acid 500 MG
Administration of 500 mg of Valproic Acid
• Valcote 500 mg
Administration of 500 mg of Valproic Acid

Locations

Country	Name	City	State
Colombia	Universidad de la Sabana	Chía

Sponsors (1)

Lead Sponsor	Collaborator
Tecnoquimicas

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(AUC) Area Under the Curve 0-48	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours	From 0 to 48 hours
Primary	Cmax	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours	From 0 to 48 hours
Secondary	Tmax	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours	From 0 to 48 hours
Secondary	Kel	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours	From 0 to 48 hours