A Phase 1 interventional study of Isotretinoin 40 mg and Isotretinoin 40 mg in Skin Infections (Acne), sponsored by GlaxoSmithKline. Completed at 1 site in Mexico. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-18.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
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.
147 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's enrollment of 36 is below the median of 157 across 118 interventional studies indexed under Cellulitis.
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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".
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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.
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initial administration of reference and cross-over to test
Drug: Isotretinoin 40 mg
initial administration of test and cross-over to reference
Drug: Isotretinoin 40 mg
Roaccutan 2 capsules of 20 mg; reference drug
Also known as: Productos Roche, Roaccutan
Oratane 2 capsules of 20 mg; test drug
Also known as: Laboratorios Dermatologicos Darier SA de CV, Oratane
Peak Plasma Concentration (CMAX) of isotretinoin
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
Area under the plasma concentration versus time curve (AUC) of isotretionin
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
Incidence od adverse events
Safety
Time frame: 20 days
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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