HealthyPhase 4NCT03914534
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
A Phase 4 study testing Valproic Acid 500 MG and Valcote 500 mg in people with Healthy, run by Tecnoquimicas at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Valproic Acid 500 MG and Valcote 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 17 Apr 2017to 12 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Drug hypersensitivity
- Angioedema or anaphylaxis history
- Pregnancy or breast-feeding
- HIV o Hepatitis B diagnosed
- Blood donor in the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Valproic Acid 500 MG, Valcote 500 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic Acid 500 MGDrug
Administration of 500 mg of Valproic Acid
Valcote 500 mgDrug
Administration of 500 mg of Valproic Acid
| Study group | Role | What they receive |
|---|---|---|
| Test Formulation of Valproic Acid | Experimental | Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2 Receives: Drug: Valproic Acid 500 MG |
| Reference Formulation of Valproic Acid | Active comparator | Valcote tablets 500 mg Single dose administered in dosing period 1 or 2 Receives: Drug: Valcote 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: From 0 to 48 hours
Cmax
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
Measured: From 0 to 48 hours
Secondary outcomes (2)
Tmax
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
Measured: From 0 to 48 hours
Kel
0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours
Measured: From 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start17 Apr 2017
- Primary completion31 Jul 2018
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnoquimicas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914534
- Sponsor's protocol ID
- Versión 1- BIO 088
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Sodium Divalproate Tablets 500 mg
- ClinicalTrials.gov ID
- NCT03914534
- Acronym / sponsor ID
- Versión 1- BIO 088
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TecnoquimicasIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Formulation of Valproic Acid | Experimental | Drug: Valproic Acid 500 MGValproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2 |
| Reference Formulation of Valproic Acid | Active comparator | Drug: Valcote 500 mgValcote tablets 500 mg Single dose administered in dosing period 1 or 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic Acid 500 MGAdministration of 500 mg of Valproic Acid | Drug | Test Formulation of Valproic Acid |
| Valcote 500 mgAdministration of 500 mg of Valproic Acid | Drug | Reference Formulation of Valproic Acid |
Primary outcome
(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
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
2 secondary outcomes
Tmax
Time frame: From 0 to 48 hours
Kel
Time frame: From 0 to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valproic Acid 500 MG and Valcote 500 mg in people with Healthy, run by Tecnoquimicas at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(AUC) Area Under the Curve 0-48 (time frame: From 0 to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.