Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

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Dr.Reddy's Laboratories

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Isotretinoin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01888328
AAI-US-102

Details and patient eligibility

About

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 fed conditions

Full description

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

Enrollment

26 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Healthy males between 18 and 45 years of age inclusive.
  • Informed of the nature of the study and given written informed consent.
  • 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

  • Hypersensitivity to isotretinoin or related compounds.
  • Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
  • Recent history of mental illness, drug addiction, drug abuse or alcoholism.
  • Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  • Received an investigational drug within the 4 weeks prior to study dosing.
  • 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.
  • Regular tobacco use in the 3 months prior to study dosing.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Isotretinoin capsules, 40 mg
Experimental group
Description:
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
Treatment:
Drug: Isotretinoin
ACCUTANE
Active Comparator group
Description:
ACCUTANE 40 mg of Roche Laboratories Inc
Treatment:
Drug: Isotretinoin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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