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Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed Conditions

Information source: Torrent Pharmaceuticals Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Torrent Pharmaceuticals Limited

Summary

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

Clinical Details

Official title: 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 Fed Conditions.

Study design: N/A

Primary outcome: bioequivalence based on Composite of Pharmacokinetics

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Bio Evaluation Centre, Torrent Pharmaceuticals Ltd.,, Village Bhat, Gandhinagar, Gujarat, India
Additional Information


Last updated: February 25, 2013

Page last updated: August 20, 2015

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