Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Lorazepam Tablets 2 mg (Drug); Ativan Tablets 2 mg (Drug)
Phase: Phase 1
Sponsored by: Mylan Pharmaceuticals
Official(s) and/or principal investigator(s):
Dorian Williams, M.D., Principal Investigator, Affiliation: Kendle International Inc.
The objective of this study was to investigate the bioequivalence of Mylan's lorazepam 2 mg
tablets to Wyeth's Ativan 2 mg tablets following a single, oral 2 mg (1 x 2 mg) dose
administered under fasting conditions.
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Lorazepam Tablets (2 mg; Mylan) and Ativan Tablets (2 mg; Wyeth) in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Minimum age: 18 Years.
Maximum age: N/A.
1. Age: 18 years and older.
2. Sex: Male and non-pregnant, non-lactating female
1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy
tests performed within 14 days prior to the start of the study and on the
evening prior to each dose administration. If dosing is scheduled on Sunday or
Monday, the HCG pregnancy test should be given within 48 hours prior to dosing
of each study period. An additional serum (Beta HCG) pregnancy test will be
performed upon completion of the study.
2. Women of childbearing potential must practice abstinence or be using an
acceptable form of contraception throughout the duration of the study.
Acceptable forms of contraception include the following:
1. intrauterine device in place for at least 3 months prior to the start of
the study and remaining in place during the study period, or
2. barrier methods containing or used in conjunction with a spermicidal agent,
3. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or
postmenopausal accompanied with a documented postmenopausal course of at
least one year.
3. During the course of the study, from study screen until study exit including the
washout period, women of childbearing potential must use a spermicide containing
barrier method of contraception in addition to their current contraceptive
device. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15%
of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of
Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE
ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical
evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and
hepatitis C tests, HIV test, and urine drug screen including amphetamine,
barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and
methadone) performed within 14 days of the initial dose of study medication.
1. Institutionalized subjects will not be used.
2. Social Habits:
1. Use of any tobacco products.
2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage
within the 48 hours prior to the initial dose of study medication.
3. Ingestion of any vitamins or herbal products within 7 days prior to the initial
dose of the study medication.
4. Any recent, significant change in dietary or exercise habits.
1. Use of any medication within the 14 days prior to the initial dose of study
2. Use of any medication known to alter hepatic enzyme activity within 28 days
prior to the initial dose of study medication.
3. Use of hormonal contraceptives and hormonal replacement therapy within three
months prior to the initial dose of study medication.
1. History of any significant chronic disease and/or hepatitis.
2. History of drug and/or alcohol abuse.
3. Acute illness at the time of either the pre-study medical evaluation or dosing.
4. Positive HIV, Hepatitis B, or Hepatitis C test.
5. Abnormal and clinically significant laboratory test results:
1. Clinically significant deviation from the Guide to Clinically Relevant
Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days
prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the
initial dose of study medication.
8. History of acute narrow angle glaucoma.
9. Allergy or hypersensitivity to lorazepam or other related products.
10. History of difficulties in swallowing, or any gastrointestinal disease which could
affect the drug absorption.
11. Consumption of grapefruit or grapefruit containing products within 7 days of drug
Locations and Contacts
Kendle International Inc., Morgantown, West Virginia 26505, United States
Mylan Pharmaceuticals Inc. - Clinical Trial Results
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Starting date: December 2004
Last updated: March 31, 2008