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Bioequivalence Study for an Isotretinoin

Primary Purpose

Skin Infections (Acne)

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

Isotretinoin 40 mg

About this trial

This is an interventional other trial for Skin Infections (Acne) focused on measuring pharmacokinetics, Isotretinoin, bioequivalence, Mexico

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male volunteers. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26 kg/m2. Anti-doping tests negative results. Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase, Lactic Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac VIH, AgsHB and RPR (luetic test), must fall within an interval between minimum and maximum values in connection to said tests accepted values.

Normal Electrocardiogram and Chest X-rays. In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant".

Exclusion Criteria:

Electrocardiographic Anomalies; radiological Anti-doping tests positive results, Positive results regarding RPR; VIH and AgsHB tests. Personal or family history of allergy to medication in question. Having any kind of allergy, since these persons are in higher risk of suffering from medicamentous allergy.

Tobacco use. Recreational drug use. Persons undergoing any medical treatment. Existence of concurrent or intercurrent disease. Existence of justified doubt regarding questionnaire answers truthfulness. Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study.

Presence of clinically important gastrointestinal diseases or malabsorption history during the last year.

Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption.

Narcotics or alcohol addiction history requiring treatment. Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A(reference)/B(test)

B(test)/A(reference)

Arm Description

initial administration of reference and cross-over to test

initial administration of test and cross-over to reference

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (CMAX) of isotretinoin

pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of isotretionin

pharmacokinetics

Secondary Outcome Measures

Incidence od adverse events

Safety

Full Information

NCT ID

NCT01863615

First Posted

December 13, 2012

Last Updated

July 13, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01863615

Brief Title

Bioequivalence Study for an Isotretinoin

Official Title

Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - Capsules. Crossover, Randomized, Single Dose, Two Treatments, Two Periods and Two Sequences With Meal (Breakfast) Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

August 26, 2011 (Actual)

Primary Completion Date

September 23, 2011 (Actual)

Study Completion Date

September 23, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent. Test product was Oratane® 20 mg (Laboratorios Dermatológicos Darier) and reference product Roaccutan® 20 mg (Productos Roche). Two capsules administered together were the single dosage. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fed conditions. The population was composed of 36 healthy volunteers, male adults between 18-45 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Infections (Acne)

Keywords

pharmacokinetics, Isotretinoin, bioequivalence, Mexico

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A(reference)/B(test)

Arm Type

Experimental

Arm Description

initial administration of reference and cross-over to test

Arm Title

B(test)/A(reference)

Arm Type

Experimental

Arm Description

initial administration of test and cross-over to reference

Intervention Type

Drug

Intervention Name(s)

Isotretinoin 40 mg

Other Intervention Name(s)

Productos Roche, Roaccutan

Intervention Description

Roaccutan 2 capsules of 20 mg; reference drug

Intervention Type

Drug

Intervention Name(s)

Isotretinoin 40 mg

Other Intervention Name(s)

Laboratorios Dermatologicos Darier SA de CV, Oratane

Intervention Description

Oratane 2 capsules of 20 mg; test drug

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (CMAX) of isotretinoin

Description

pharmacokinetics

Time Frame

0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours postdosage

Title

Area under the plasma concentration versus time curve (AUC) of isotretionin

Description

pharmacokinetics

Time Frame

0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 and 96.0 hours postdosage

Secondary Outcome Measure Information:

Title

Incidence od adverse events

Description

Safety

Time Frame

20 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male volunteers. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26 kg/m2. Anti-doping tests negative results. Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase, Lactic Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac VIH, AgsHB and RPR (luetic test), must fall within an interval between minimum and maximum values in connection to said tests accepted values. Normal Electrocardiogram and Chest X-rays. In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant". - Exclusion Criteria: Electrocardiographic Anomalies; radiological Anti-doping tests positive results, Positive results regarding RPR; VIH and AgsHB tests. Personal or family history of allergy to medication in question. Having any kind of allergy, since these persons are in higher risk of suffering from medicamentous allergy. Tobacco use. Recreational drug use. Persons undergoing any medical treatment. Existence of concurrent or intercurrent disease. Existence of justified doubt regarding questionnaire answers truthfulness. Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study. Presence of clinically important gastrointestinal diseases or malabsorption history during the last year. Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption. Narcotics or alcohol addiction history requiring treatment. Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64600

Country

Mexico

12. IPD Sharing Statement

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Bioequivalence Study for an Isotretinoin

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