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Bioequivalence Study for an Isotretinoin

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Infections (Acne)

Intervention: Isotretinoin 40 mg (Drug); Isotretinoin 40 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


The objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent. Test product was Oratane« 20 mg (Laboratorios Dermatolˇgicos 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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Peak Plasma Concentration (CMAX) of isotretinoin

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

Secondary outcome: Incidence od adverse events


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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.


Locations and Contacts

GSK Investigational Site, Monterrey, Nuevo Le├│n 64600, Mexico
Additional Information

Starting date: August 2011
Last updated: December 5, 2013

Page last updated: August 23, 2015

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