Bioequivalence Study of Sodium Divalproate Tablets 500 mg
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 healthy
Started Apr 2017
Typical duration for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2019
CompletedFirst Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedApril 16, 2019
April 1, 2019
1.3 years
April 11, 2019
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
(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
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 Outcomes (2)
Tmax
From 0 to 48 hours
Kel
From 0 to 48 hours
Study Arms (2)
Test Formulation of Valproic Acid
EXPERIMENTALValproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2
Reference Formulation of Valproic Acid
ACTIVE COMPARATORValcote tablets 500 mg Single dose administered in dosing period 1 or 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tecnoquimicaslead
Study Sites (1)
Universidad de la Sabana
Chía, Colombia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
April 16, 2019
Study Start
April 17, 2017
Primary Completion
July 31, 2018
Study Completion
February 12, 2019
Last Updated
April 16, 2019
Record last verified: 2019-04