Status:
COMPLETED
Bioequivalence Study for an Isotretinoin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Skin Infections (Acne)
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
August 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01863615
Start Date
August 26 2011
End Date
September 23 2011
Last Update
July 18 2017
Active Locations (1)
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1
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64600