Healthy
Conditions
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.
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.
Interventions
Administration of 500 mg of Valproic Acid
DRUGValcote 500 mg
Administration of 500 mg of Valproic Acid
Sponsors
Tecnoquimicas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (AUC) Area Under the Curve 0-48 | From 0 to 48 hours | 0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours |
| Cmax | From 0 to 48 hours | 0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | From 0 to 48 hours | 0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours |
| Kel | From 0 to 48 hours | 0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours |
Countries
Colombia
Outcome results
None listed