NCT01800227已完成1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- bioequivalence based on Composite of Pharmacokinetics
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
bioequivalence based on Composite of Pharmacokinetics
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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