Bioequivalence Study of Torrent Pharmaceuticals Ltd’s Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions

Overview

Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label

Full Title of Study: “An Open Label, Randomised, 2-Period, 2-Treatment, 2-Sequence, Crossover, Single-Dose Bioequivalence Study of FDC of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Actoplus Met® 15 mg/850 mg Tablets (Reference Formulation, Takeda Pharmaceuticals America Inc., USA) in Healthy Human Volunteers Under Fasting Conditions.”

Study Type

  • Study Type: Interventional
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: Torrent’s Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets

Clinical Trial Outcome Measures

Primary Measures

  • bioequivalence based on Composite of Pharmacokinetics
    • Time Frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 14.0, 15.0, 16.0, 17.0, 18.0, 20.0, 24.0, 36.0, 48.0, 72.0, 96.0, 120.0 hours after dose administration.
    • bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% – 125.00% for AUC-unf, AUCo-t and Cmax.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Torrent Pharmaceuticals Limited
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.