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Trial record 6 of 163 for:    ISOTRETINOIN

Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

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ClinicalTrials.gov Identifier: NCT01888289
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

Condition or disease Intervention/treatment Phase
Healthy Drug: Isotretinoin Phase 1

Detailed Description:
An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions
Study Start Date : July 2001
Actual Primary Completion Date : August 2001
Actual Study Completion Date : September 2001

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Arm Intervention/treatment
Experimental: Isotretinoin capsules, 40 mg
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
Drug: Isotretinoin
Isotretinoin Capsules,40 mg
Other Name: ACCUTANE

Active Comparator: ACCUTANE
ACCUTANE 40 mg of Roche Laboratories Inc
Drug: Isotretinoin
Isotretinoin Capsules,40 mg
Other Name: ACCUTANE




Primary Outcome Measures :
  1. Area under curve (AUC) [ Time Frame: Pre-dose (0) and 0.5, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs ]


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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:

  1. Healthy males between 18 and 45 years of age inclusive.
  2. Informed of the nature of the study and given written informed consent.
  3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

  1. Hypersensitivity to isotretinoin or related compounds.
  2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
  3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
  4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  5. Received an investigational drug within the 4 weeks prior to study dosing.
  6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
  7. Regular tobacco use in the 3 months prior to study dosing.

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): NCT01888289


Locations
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United States, North Carolina
AAI
Quadrangle Drive, Chapel Hill,, North Carolina, United States, 27514
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. Ralph Scallion , MD AAI

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01888289     History of Changes
Other Study ID Numbers: AAI-US-101
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: November 2001
Additional relevant MeSH terms:
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Isotretinoin
Dermatologic Agents