- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02312609
Bioequivalence Study of Minocycline HCl 135 mg ER Tablet Sunder Fed Conditions
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Minocycline Hydrochloride 135 mg Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of OHM Laboratories, USA. (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With SolodynTM Extended Release Tablets (Containing Minocycline Hydrochloride 135 mg) of AAI Pharma, Inc. in Healthy, Adult, Male, Human Subjects Under Fed Condition
Study Overview
Detailed Description
Test for drugs of abuse (opiates and cannabinoids) in urine and breath test for alcohol were carried out prior to admission in each period of the study. Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served to the study subjects.
Thirty minutes after start of this breakfast, a single oral dose of minocycline hydrochloride extended release tablet 135 mg of either test or reference investigational product was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel.
During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Volunteers who met the following criteria were included in the study
- Were in the age range of 18-45 years
- Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases
- Had voluntarily given written informed consent to participate in this study
- 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
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
- Had a non-vegetarian diet habit
Exclusion Criteria:
- Hypersensitivity to minocycline or related group of drugs or to any other drug
- History of diarrhoea in last one week or antibiotic induced diarrhoea
- Frequent episodes of light headedness, vertigo and dizziness preceding one week
- History of photosensitivity
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma
- History of any psychiatric illness, which may impair the ability to provide written informed consent
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection
- Presence of values which are out of acceptable limits for total white blood cells count, differential WBC count or platelet count
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
- 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
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray
- Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period
- 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
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test
Minocycline hydrochloride extended release tablets 135 mg
|
extended release tablets 135 mg
|
Active Comparator: Reference
Solodyn Extended Release Tablets 135 mg
|
extended release tablets 135 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration versus time curve (AUC) of Minocycline
Time Frame: 0-96 hrs
|
0-96 hrs
|
Peak Plasma Concentration (Cmax) of Minocycline
Time Frame: 0-96 hrs
|
0-96 hrs
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 238_MINOC_08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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