Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT01603173
First received: April 19, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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 fasting condition in normal, healthy, adult, human subjects.


Condition Intervention Phase
Fasting State
Drug: Quetiapine Fumarate Tablets 25 mg
Drug: Quetiapine Fumarate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Fasting Condition

Resource links provided by NLM:


Further study details as provided by IPCA Laboratories Ltd.:

Primary Outcome Measures:
  • Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Area Under Curve (AUC)and Cmax Sampling Hours: 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.


Enrollment: 54
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine Fumarate Tablets 25 mg
Quetiapine Fumarate Tablets 25 mg of M/s Ipca Laboratories Limited, India
Drug: Quetiapine Fumarate Tablets 25 mg
25 mg tablet once a day
Other Name: Test Product
Active Comparator: Seroquel®
Seroquel® (Quetiapine Fumarate) Tablets 25 mg of M/s AstraZeneca Pharmaceuticals LP, USA
Drug: Quetiapine Fumarate
25 mg tablet once a day
Other Name: Seroquel®

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 fasting 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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603173

Locations
India
Accutest Research Lab (I) Pvt. Ltd.
Ahmedabad, Gujarat, India
Sponsors and Collaborators
IPCA Laboratories Ltd.
Investigators
Principal Investigator: Dr. Nirav Gandhi, M.D. Accutest Research Lab (I) Pvt. Ltd.
  More Information

No publications provided

Responsible Party: IPCA Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01603173     History of Changes
Other Study ID Numbers: Ipca/ARL/233
Study First Received: April 19, 2012
Last Updated: May 21, 2012
Health Authority: India: Ministry of Health
United States: Institutional Review Board

Additional relevant MeSH terms:
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014