Bioequivalence of two levothyroxine tablet formulations in healthy Indian voulnteers

Not Applicable

Completed

Registration Number: CTRI/2012/12/003261

Lead Sponsor: GlaxoSmithKline Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

1.Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, 12 lead ECG and chest-x-ray. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Medical Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with total T4 (4.5 -12.0 Âµg/dL), T3 (0.79 - 1.49 ng/mL) and TSH (21 weeks - 20 years: 0.7 - 6.4 ÂµIU/mL, 21 - 54 years: 0.4 - 4.2 ÂµIU/mL) values outside the normal range should always be excluded from enrollment (Interpath Lab Instructions, 2010).

2.Males between 18 and 50 years of age (both inclusive), who are willing to participate in the study and provide a written signed and dated informed consent.

3.Body weight of 60 kg and BMI within the range 18.5-24.9 kg/m2 (inclusive).

4.Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Exclusion Criteria

1.A positive pre-study urine drug screen.

2.A positive test for HIV antibody.

3.Subject has clinically significant abnormal values of laboratory parameters.

4.Regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units. One unit is equivalent to 8 g of alcohol: a half-pint ( approximate 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits (CTRI, 2010).

5.The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

6.Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

7.Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St Johnâ??s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.

8.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.

9.Where participation in another study would result in donation of blood or blood products in excess of 350 ml within a 90 day period prior to this study.

10.Unwillingness or inability to follow the procedures outlined in the protocol.

11.Subject is mentally or legally incapacitated or the subject is incapable of understanding the informed consent.

12.Subject has any evidence of impaired renal, hepatic, cardiac, lung or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.

13.History of sensitivity to heparin or heparin-induced thrombocytopenia.

14.Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.

15.Subject is intolerant to venipuncture.

16.Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication