Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg | NCT03634371

Studies
Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

NCT03634371

Sponsor

Tecnoquimicas

Status

Unknown status

Last Update Posted

Aug 16, 2018Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Healthy

Interventions

Drug Levothyroxine 150 mcg
Drug Eutirox 150 mcg

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2018Actual

Primary Completion Date

Oct 6, 2018Estimated

Completion Date

Oct 6, 2018Estimated

First Submitted Date

Aug 12, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 16, 2018Actual

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

Aug 14, 2018

Last Update Posted Date

Aug 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mauricio Vargas, Biopharmaceutical Studies Director, TecnoquimicasPrincipal Investigator

Lead Sponsor

TecnoquimicasINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

Detailed Description

Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine administration (e.g. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Tecnoquimicas modified its Levothyroxine tablets formulation in order to comply with new pharmacopeical specifications. It will then evaluate the impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test formulation) relative to the reference formulation from Merck (Reference formulation)

This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a single dose (4 x 150 mcg tablets = 600 mcg) of the test formulation of levothyroxine and reference formulation of levothyroxine separately in each treatment period. There will be two treatment sequences (AB, BA) and a 42 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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Formulation of Levothyroxine	Experimental	Levothyroxine sodium tablets 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2	Drug: Drug Levothyroxine 150 mcg
Reference formulation of Levothyroxine	Active Comparator	Eutirox 150 mcg Single dose of 600 mcg administered in dosing period 1 or 2	Drug: Drug Eutirox 150 mcg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drug Levothyroxine 150 mcg	Drug	Administration of a 600 mcg levothyroxine dose	Test Formulation of Levothyroxine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(AUC) Area Under the Curve 0-48 for T4	-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours	From 0 to 48 hours
Cmax for T4	-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours	From 0 to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
AUC 0-48 for T3	-0.5, -0.25, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours	From 0 to 48 hours
Cmax for T3		From 0 to 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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided