Overview

Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
Male
Summary
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Minocycline hydrochloride extended release tablets 135 mg manufactured by OHM Laboratories Inc. with SolodynTM extended release tablets 135 mg manufactured by AAI Pharma, Inc Wilmington, NC 28405 and manufactured for Medicis, The Dermatology Company Scottsdale, AZ 85258 in healthy, adult, human, male subjects under fed conditions.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Treatments:
Minocycline
Criteria
Inclusion Criteria:

Volunteers who met the following criteria were included in the study

1. Were in the age range of 18-45 years

2. Were neither overweight nor underweight for their height as per the Life Insurance
Corporation of India height/weight chart for non-medical cases

3. Had voluntarily given written informed consent to participate in this study

4. Were of normal health as determined by medical history and physical examination of the
subjects performed within 21 days prior to the commencement of the study

5. Male subjects and:

- Whose female partner(s) was/were not pregnant or was/were not planning to become
pregnant

- Whose female partner(s) was/were using at least one highly effective and one
acceptable method of birth control (at the same time) for the duration of the
study and for 2 weeks after completion of the study, such as condoms, foams,
jellies, diaphragm, intrauterine device (IUD), or abstinence. Dual method of
contraception must be used during the study and for 2 weeks after its
discontinuation

- Whose female partner was surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, hysterectomy)

- Those using condoms even if vasectomy has been done; during the study and for 2
weeks after completion of the study

6. Had a non-vegetarian diet habit

Exclusion Criteria:

1. Hypersensitivity to minocycline or related group of drugs or to any other drug

2. History of diarrhoea in last one week or antibiotic induced diarrhoea

3. Frequent episodes of light headedness, vertigo and dizziness preceding one week

4. History of photosensitivity

5. Any evidence of organ dysfunction or any clinically significant deviation from the
normal, in physical or clinical determinations

6. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary,
neurological or haematological disease, diabetes or glaucoma

7. History of any psychiatric illness, which may impair the ability to provide written
informed consent

8. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis
infection

9. Presence of values which are out of acceptable limits for total white blood cells
count, differential WBC count or platelet count

10. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)

11. Presence of values which are out of acceptable limits for serum creatinine, blood urea
nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase
(ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum
cholesterol

12. Clinically abnormal chemical and microscopic examination of urine defined as presence
of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).

13. Clinically abnormal ECG or Chest X-ray

14. Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining
from smoking for the duration of each study period

15. History of drug dependence or excessive alcohol intake on a habitual basis of more
than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or
1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the
duration of each study period

16. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study

17. Participation in any clinical trial within 12 weeks preceding Day 1 of this study

18. Subjects who, through completion of this study, would have donated and /or lost more
than 350 ml of blood in the past 3 months other than study participation