Overview

Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
IPCA Laboratories Ltd.
Treatments:
Metoprolol
Criteria
Inclusion Criteria:

1. 18 to 45 years old, both inclusive.

2. Sex: Males and/or non-pregnant, non-lactating females.

3. BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;

4. Able to communicate effectively with study personnel and willingness to follow the
protocol requirements as evidenced by written informed consent.

5. Able to give written informed consent to participate in the study.

6. All volunteers must be judged by the principal or co-investigator or physician as
normal and healthy during a pre-study safety assessment performed within 21 days of
the first dose of study medication which will include:

- A physical examination with no clinically significant finding.

- Results within normal limits or clinically non-significant for the tests
mentioned in List of Laboratory Parameters:

- Additional tests and/or examinations may be performed, if necessary, based on
Principal Investigator discretion.

- All results will be assessed against the laboratory normal ranges current at the
time of testing and a copy of the normal ranges used will be included in the
study documentation.

Exclusion Criteria:

1. History of allergic responses to Metoprolol Succinate or other related drugs, or any
of its formulation ingredients.

2. Have significant diseases or clinically significant abnormal findings during
screening, [medical history, physical examination, laboratory evaluations, ECG, chest
X-ray recording, obstetrics and gynecological history and examination along with PAP
smear (for female volunteers) & transvaginal ultrasonography (for female volunteers)].

3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal,
renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes,
psychosis or any other body system.

4. History or presence of bronchial asthma.

5. Use of any hormone replacement therapy within 3 months prior to study medication
dosing.

6. A depot injection or implant of any drug within 3 months prior to administration of
study medication.

7. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of
study medication.

8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.

9. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those
who cannot refrain from smoking during the study period.

10. History of difficulty with donating blood or difficulty in accessibility of veins.

11. History of allergic response to heparin.

12. A positive hepatitis screen (includes subtypes B & C).

13. A positive test result for HIV antibody and / or syphilis (RPR/VDRL).

14. Volunteers who have donated blood (1 unit or 450 mL) within 90 days prior to the
initial dose of the study drug or have blood loss, excluding volume drawn at screening
for this study, (≤100 mL within 30 days; ≤200 mL within 60 days; >200 mL within 90
days) prior to initial dose of study drug.

15. History of difficulty in swallowing, or of any gastrointestinal disease which could
affect drug absorption.

16. Intolerance to venipuncture

17. Any food allergy, intolerance, restriction or special diet that, in the opinion of the
Principal Investigator or Co-Investigator, could contraindicate the volunteer's
participation in this study.

18. Volunteers who have received a known investigational drug within five elimination half
life of the administered drug prior to the initial dose of study drug or who have
participated in a clinical drug study or bioequivalence study within 90 days prior to
the initial dose of study drug, whichever is greater.

19. Found positive in urine test for drugs of abuse done before check-in of period I.