Bioequivalence Study of Sodium Divalproate Tablets 500 mg | NCT03914534

Studies
Bioequivalence Study of Sodium Divalproate Tablets 500 mg

NCT03914534

Sponsor

Tecnoquimicas

Status

Completed

Last Update Posted

Apr 16, 2019Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Healthy

Interventions

Valproic Acid 500 MG
Valcote 500 mg

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2017Actual

Primary Completion Date

Jul 31, 2018Actual

Completion Date

Feb 12, 2019Actual

First Submitted Date

Apr 11, 2019

First Submission Date that Met QC Criteria

Apr 11, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Formulation of Valproic Acid	Experimental	Valproic Acid tablets 500 mg Single dose administered in dosing period 1 or 2	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	Drug: Valcote 500 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valproic Acid 500 MG	Drug	Administration of 500 mg of Valproic Acid	Test Formulation of Valproic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(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

Measure	Description	Time Frame
Tmax	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours	From 0 to 48 hours
Kel	0, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 y 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de la Sabana		Chía			Colombia

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

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