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Trial record 14 of 165 for:    ISOTRETINOIN

Bioequivalence Study for an Isotretinoin

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ClinicalTrials.gov Identifier: NCT01863615
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Skin Infections (Acne) Drug: Isotretinoin 40 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 26, 2011
Actual Primary Completion Date : September 23, 2011
Actual Study Completion Date : September 23, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A(reference)/B(test)
initial administration of reference and cross-over to test
Drug: Isotretinoin 40 mg
Roaccutan 2 capsules of 20 mg; reference drug
Other Names:
  • Productos Roche
  • Roaccutan

Drug: Isotretinoin 40 mg
Oratane 2 capsules of 20 mg; test drug
Other Names:
  • Laboratorios Dermatologicos Darier SA de CV
  • Oratane

Experimental: B(test)/A(reference)
initial administration of test and cross-over to reference
Drug: Isotretinoin 40 mg
Roaccutan 2 capsules of 20 mg; reference drug
Other Names:
  • Productos Roche
  • Roaccutan

Drug: Isotretinoin 40 mg
Oratane 2 capsules of 20 mg; test drug
Other Names:
  • Laboratorios Dermatologicos Darier SA de CV
  • Oratane




Primary Outcome Measures :
  1. Peak Plasma Concentration (CMAX) of isotretinoin [ 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 ]
    pharmacokinetics

  2. Area under the plasma concentration versus time curve (AUC) of isotretionin [ 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 ]
    pharmacokinetics


Secondary Outcome Measures :
  1. Incidence od adverse events [ Time Frame: 20 days ]
    Safety



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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".

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863615


Locations
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Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01863615     History of Changes
Other Study ID Numbers: 116615
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Keywords provided by GlaxoSmithKline:
pharmacokinetics
Isotretinoin
bioequivalence
Mexico
Additional relevant MeSH terms:
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Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Skin Diseases
Isotretinoin
Dermatologic Agents