An Open Label, Randomized, Two-Treatment, Four-Period, Two-Sequence, Single Oral Dose, Crossover, Fully Replicate Bioequivalence Study of SEDRONATE (35 mg) (Risedronate Sodium 35 mg Tablets) of the Government Pharmaceutical Organization, Thailand with Actonel Once-a-Week 35 mg (Risedronate Sodium 35 mg Tablets) of Norwich Pharmaceuticals, Inc., United States of America in Normal, Healthy, Adult Human Subjects under Fasting Conditions
- Conditions
- Healthy male and female volunteers
- Registration Number
- TCTR20190329002
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 18
i. Non-smokers, healthy, adult, human subjects between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
ii. Having a Body Mass Index (BMI) between 18.0 and 30.0 (both inclusive), calculated as weight in kg/height in meter square.
iii. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (postero-anterior view).
iv. Able to understand and comply with the study procedures, in the opinion of the investigator.
v. Able to give voluntary written informed consent for participation in the trial.
vi. Having Creatinine Clearance value within clinically acceptable limit at the time of screening
vii. In case of female subjects:
• Surgically sterilized at least 06 months prior to study participation;
Or
• If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
And
• Serum pregnancy test must be negative.
i. Known hypersensitivity to Risedronate Sodium or any excipients or any related drug or any substance.
ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
iii. Ingestion or Use of any medication [prescribed medication & over the counter (OTC) medication including herbal remedies] at any time in 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
v. Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in Period-I.
vi. Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks), tobacco, tobacco containing products (gutkha, pan/pan masala) 24 hours prior to IMP administration of period-I.
vii. Clinically significant abnormal laboratory values of serum calcium and serum phosphorus at the time of screening
viii. Smokers or who have smoked within last 06 months prior to start of the study
ix. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period-I.
x. The presence of clinically significant abnormal laboratory values during screening.
xi. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
xii. History or presence of seizure or psychiatric disorder
xiii. A history of difficulty with donating blood.
xiv. Difficulty in swallowing solids dosage forms like tablets or capsules.
xv. Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
xvi. Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
xvii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
xviii. A positive test result for HIV antibody (I & II).
xix. An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
xx. Nursing mothers (for female subjects).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters derived from drug concentration profile 25 blood sampling timepoints from 0-72 hour post-dose Bioanalysis and statistical data analysis
- Secondary Outcome Measures
Name Time Method Adverse Events/ Serious Adverse Events Pre-dose and at 01, 03, 06, 09, 12, 24, 36, 48 and 60 hours post-dose Physical and biochemical examination eg. vital signs, laboratory assessment