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Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition

Primary Purpose

Fed

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Quetiapine Fumarate Tablets 25 mg
Quetiapine Fumarate
Sponsored by
IPCA Laboratories Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fed

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and female human subjects, age in the range of 25 - 45 years and weight ≥60 kg.
  2. BMI within range of 18.5kg/m2 - 30 kg/m2.
  3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
  4. Subjects with blood pressure more than or equal to 110/70mmHg at the time of screening and at the time of check in for each study period.
  5. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
  6. Willingness to follow the protocol requirements as evidenced by written informed consent.
  7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.
  8. No history of drug abuse in the past one year.
  9. Non-smokers and non-alcoholics.
  10. For female subject is child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies,Diaphragm, Intrauterine device and Abstinence.

OR

- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Exclusion Criteria:

  1. Known history of hypersensitivity to Quetiapine, or related drugs.
  2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
  3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
  4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
  5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
  6. History of malignancy or other serious diseases.
  7. Refusal to abstain from food for at least ten (10.00) hours prior to study drug administration and for at least four (04.00) hours post-dose, in each study period.
  8. Any contraindication to blood sampling or difficulty in accessibility of veins.
  9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
  10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
  11. Blood donation within 90 days prior to the commencement of the study.
  12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
  13. Found positive in breath alcohol test done before check-in for each study period.
  14. Found positive in urine test for drugs of abuse done before check-in for each study period.
  15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.
  16. History of problem in swallowing Tablet(s).
  17. Female subject, demonstrating positive urine pregnancy test at the time of screening.
  18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
  19. Female subject, currently breast feeding or lactating.
  20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.

Sites / Locations

  • Accutest Research Lab (I) Pvt. Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quetiapine Fumarate Tablets 25 mg

Seroquel®

Arm Description

Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India

Seroquel® (Quetiapine Fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA

Outcomes

Primary Outcome Measures

Bioequivalence is based on Cmax and AUC parameters.
Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2012
Last Updated
July 5, 2012
Sponsor
IPCA Laboratories Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01603186
Brief Title
Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition
Official Title
A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fed Condition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IPCA Laboratories Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.
Detailed Description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: Seroquel® (Quetiapine fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA, under fed condition in normal, healthy, adult, human subjects in a randomized crossover study. The study was conducted with 54 healthy adult subjects. In each study period, a single 25 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position. The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine Fumarate Tablets 25 mg
Arm Type
Experimental
Arm Description
Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India
Arm Title
Seroquel®
Arm Type
Active Comparator
Arm Description
Seroquel® (Quetiapine Fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate Tablets 25 mg
Other Intervention Name(s)
Test Product
Intervention Description
25 mg tablet once a day
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Other Intervention Name(s)
Seroquel®
Intervention Description
25 mg tablet once a day
Primary Outcome Measure Information:
Title
Bioequivalence is based on Cmax and AUC parameters.
Description
Pre-dose and at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female human subjects, age in the range of 25 - 45 years and weight ≥60 kg. BMI within range of 18.5kg/m2 - 30 kg/m2. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature). Subjects with blood pressure more than or equal to 110/70mmHg at the time of screening and at the time of check in for each study period. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required). Willingness to follow the protocol requirements as evidenced by written informed consent. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study. No history of drug abuse in the past one year. Non-smokers and non-alcoholics. For female subject is child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies,Diaphragm, Intrauterine device and Abstinence. OR - is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject). Exclusion Criteria: Known history of hypersensitivity to Quetiapine, or related drugs. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study. History of malignancy or other serious diseases. Refusal to abstain from food for at least ten (10.00) hours prior to study drug administration and for at least four (04.00) hours post-dose, in each study period. Any contraindication to blood sampling or difficulty in accessibility of veins. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug. Refusal to avoid the use of xanthine-containing food or beverages (chocolates,tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period. Blood donation within 90 days prior to the commencement of the study. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests. Found positive in breath alcohol test done before check-in for each study period. Found positive in urine test for drugs of abuse done before check-in for each study period. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period. History of problem in swallowing Tablet(s). Female subject, demonstrating positive urine pregnancy test at the time of screening. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period. Female subject, currently breast feeding or lactating. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nirav Gandhi, M.D.
Organizational Affiliation
Accutest Research Lab (I) Pvt. Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Accutest Research Lab (I) Pvt. Ltd.
City
Ahmedabad
State/Province
Gujarat
Country
India

12. IPD Sharing Statement

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Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition

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