Investigator initiated study
- Registration Number
- CTRI/2020/01/022940
- Lead Sponsor
- Erode Cancer centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1)Study participant who is able to provide written informed consent.
2)Study participant is a healthy adult human male (age 18 - 45 years) or healthy Post menopausal female (age 40-60 years).
3)Study participant Body Mass Index of 18.5 kg/m2 and 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women.
4)Study participant with baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
5)Study participant with heart rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14/min and not more than 18/min.
6)Study participant has normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period 1.
7)Study participant with normal ECG, chest X-ray and vital signs.
8)Availability of a study participant for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
9)Study participant is postmenopausal with spontaneous amenorrhea for at least 01 year.
Or
Study participant with surgical menopause (who has undergone hysterectomy at least 01 year back).
1)Study participant who is incapable of understanding the informed consent.
2)Study participant with history of hypersensitivity or idiosyncratic reaction to active or inactive ingredient in the Teriparatide or any other related drug or to milk, eggs or chicken.
3)Study participant with any evidence of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 05 years), diabetes, psychosis, eye disorders will not be eligible for the study.
4)Study participant who regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the duration of each study period.
5)Study participant who are currently on any medications or supplements known to cause systemic hypotension.
6)Study participant who has taken over the counter or prescribed medications, including any enzyme modifying drugs (known to induce or inhibit hepatic enzyme activity) or any systemic medication within the past 30 days prior to dosing in first period.
7)Study participant who has taken any over the counter medicinal products, herbal medications within 07 days prior to study check-in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study
8)Study participant who received previous treatment with: bisphosphonates, hormonal (estrogen/progestogen) replacement therapy (HRT), tibolone, raloxifene, calcitonin, within 6 months prior to randomization; systemic corticosteroid use >2 weeks of >5 mg prednisone or equivalent/average day within the past 3 months prior to randomization; anabolic androgens within six months prior to randomization; any prior use of PTH for more than 1 week; strontium ranelate at any time prior to screening;
9)Study participant with Hypercalcemia, serum calcium >10.2 mg/dL; Vitamin D 25-(OH) serum levels of less than12 ng/mL.
10)Study participant with history of cardiovascular signs, symptoms, conditions, or diseases.
11)Study participant with history of any psychiatric illness, which may impair the ability to provide written, informed consent.
12)Study participant with history of alcohol or substance abuse within the last 05 years.
13)Study participant with clinically significant abnormal values of laboratory parameters.
14)Study participant had participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 03 months.
15)Study participant who is unable to or unlikely to be compliant with protocol requirements or restrictions.
16)Study drug is contraindicated for medical reasons.
17)Study participant who is intolerant to venipuncture.
18)Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to study or used oral contraceptives within 14 days before dosing.
19)Female volunteer who demonstrates a positive pregnancy test.
Each female study volunteer will be screened for pregnancy at screening and at check-in before each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the PK profiles of single dose of Teriparatide 4 mg Capsule (T1) and Teriparatide 4 mg Capsule (T2) with Teriparatide 20 mcg Subcutaneous injection among healthy, adult male and/or post-menopausal females under fasting and fed conditions.Timepoint: 00.00, 00.08, 00.17, 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 06.00 and 24.00 hours
- Secondary Outcome Measures
Name Time Method 1) To evaluate the effect of food on pharmacokinetics of Test Formulations. <br/ ><br>2) To evaluate participant preference for the drugs administered. <br/ ><br>3) To monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Teriparatide formulations (Capsule and Subcutaneous injection) under fasting and fed conditions <br/ ><br>Timepoint: 00.00, 00.08, 00.17, 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 06.00 and 24.00 hours