Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01634386
First received: June 27, 2012
Last updated: July 2, 2012
Last verified: July 2012

June 27, 2012
July 2, 2012
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Complete list of historical versions of study NCT01634386 on ClinicalTrials.gov Archive Site
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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets Under Fasting Conditions
An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, USA] in Healthy Human Volunteers Under Fasting Condition.

Objective:

Primary objective of the present study was to compare the single dose bioequivalence of Torrent's Quetiapine Fumarate Tablets 1 × 25 mg. Dosing periods of the fed were separated by a washout period of 7 days.

Study Design:

Open label, Randomized, Two-Way, Crossover, Single-Dose Bioequivalence Study

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Interventional
Phase 1
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Healthy
Drug: Torrent's Quetiapine Fumarate Tablets
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

  • Sex: male.
  • Age: 18 - 45 years.
  • Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  • Healthy and willing to participate in the study.
  • Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  • Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

  • Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  • Clinically significant abnormal ECG or Chest X-ray.
  • Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  • Pulse rate less than 50/minute or more than 100/minute.
  • Oral temperature less than 95°P or more than 98.6°P.
  • Respiratory rate less than 12/minute or more than 20/minute
  • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  • History of alcohol or drug abuse
  • Positive breath alcohol test
  • Recent history of kidney or liver dysfunction.
  • History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  • Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  • History of heart failure.
  • HIV, HCV, HBsAg positive volunteers.
  • Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
  • Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  • Administration of any study drug in the period 0 to 3 months before entry to the study.
  • History of significant blood loss due to any reason, including blood donation in the past 3 months.
  • History of pre-existing bleeding disorder.
  • Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  • Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01634386
PK-08-189
No
Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals Limited
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Torrent Pharmaceuticals Limited
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP