Healthy
Conditions
Brief summary
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc. Dosing periods of studies were separated by a washout period of 12 days and 11 days respectively. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label
Interventions
DRUGTorrent's Pioglitazone
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bioequivalence based on Composite of Pharmacokinetics | 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. |
Countries
India
Outcome results
None listed