Bioequivalence Study for an Isotretinoin

NCT01863615 | Completed Phase 1

• 1 other identifier: 116615
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Infections (Acne)

Keywords

pharmacokinetics; Isotretinoin; bioequivalence; Mexico

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (CMAX) of isotretinoin

  pharmacokinetics

  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

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

  pharmacokinetics

  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 Outcomes (1)

• Incidence od adverse events

  20 days

Study Arms (2)

A(reference)/B(test)

EXPERIMENTAL

initial administration of reference and cross-over to test

Drug: Isotretinoin 40 mg

B(test)/A(reference)

EXPERIMENTAL

initial administration of test and cross-over to reference

Drug: Isotretinoin 40 mg

Interventions

Isotretinoin 40 mg DRUG

Roaccutan 2 capsules of 20 mg; reference drug

Also known as: Productos Roche, Roaccutan

A(reference)/B(test); B(test)/A(reference)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Monterrey, Nuevo León, 64600, Mexico

Location

Related Links

• Results for study 116615 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Cellulitis; Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: May 29, 2013
• Study Start: August 26, 2011
• Primary Completion: September 23, 2011
• Study Completion: September 23, 2011
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

ME (1)