Last updated: 11/07/2018 11:37:17
A Study to determine Bioequivalence of Isotretinoin in healthy male subjects under fed condition
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Bioequivalence Study for an Isotretinoin Pharmaceutical Preparation - capsules. Open, crossover, randomized, single dose, three treatments, three periods and six sequences with meal (breakfast) study
Trial description: This is an open-label, crossover, randomized, single dose, three treatments, three periods and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin. Bioequivalence will be compared between the reference medication one (T1) vs the test medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3): (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they are bioequivalent.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Area under the plasma concentration-time curve from zero hours to last quantifiable time (AUC0-t)
Timeframe: Pre-dose and 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 post dose in each treatment period
Area under the plasma concentration-time curve from zero hours to infinite (AUC0-infinity)
Timeframe: Pre-dose and 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 post dose in each treatment period
Maximum drug concentration (Cmax)
Timeframe: Pre-dose and 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 post dose in each treatment period
Time to maximum drug concentration (Tmax)
Timeframe: Pre-dose and 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 post dose in each treatment period
Secondary outcomes:
Not applicable
Interventions:
Drug: Isotretinoin: Reference Medication 1
Drug: Isotretinoin: Reference Medication 2
Drug: Isotretinoin: Test Medication
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Everardo Piñeyro-Garza, Magdalena Gómez-Silva, María Elena Gamino Peña, Jonathan Palmer, Arturo Berber. Isotretinoin conundrum: a randomized, open-label, crossover study in Mexico to evaluate the bioavailability and bioequivalence of three pharmaceutical preparations of isotretinoin in healthy participants. Int J Clin Pharmacol Ther. 2015;53(10):897-904.
Medical condition
Acne Vulgaris
Product
isotretinoin
Collaborators
Not applicable
Study date(s)
May 2013 to July 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Included in study will be male volunteers.
- Ages between 18 and 45 years old.
- Electrocardiographic Anomalies; radiological
- Anti-doping tests positive results,
Inclusion and exclusion criteria
Inclusion criteria:
- Included in study will be male volunteers.
- Ages between 18 and 45 years old.
- BMI (Body Mass Index) between 20 to 26 kilogram/meter square (kg/m^2).
- Anti-doping tests negative results.
- Negative test results for Ac human immunodeficiency virus (HIV), HBsAg (hepatitis B surface antigen), and rapid plasma regain (RPR; syphilis test).
- 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 (ALP), Lactic Dehydrogenase, Asparate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac HIV, HBsAg and RPR, must fall within an interval between minimum and maximum values in connection to said tests accepted values.
- Normal Electrocardiogram (ECG) and Chest X-rays.
- Complete the scale ‘Columbia Suicide Severity Rating Scale’ (C-SSRS), before and after each dosification period.
- Obtain a grade of zero in the C-SSRS.
- Signed the Informed Consent corresponding to the bioequivalence study.
- 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; HIV and HBsAg 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 medication allergy.
- Tobacco use.
- Persons undergoing any medical treatment.
- Existence of concurrent or intercurrent disease.
- History psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia).
- 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.
- Drugs or alcohol addiction history requiring treatment.
- Refuse to take the scale ‘C-SSRS, before and after each dosification period.
- Obtain a grade greater than zero in the C-SSRS.
- Do not sign the Informed Consent corresponding to the bioequivalence study.
- Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2013-15-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 200115 can be found on the GSK Clinical Study Register.
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