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
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.
