A clinical trial to study pharmacokinetics of ALDP 001 in the healthy adult human subjects
- Registration Number
- CTRI/2022/05/042349
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (�²-HCG) pregnancy test performed within 28 days prior to dosing day. They must be using an acceptable form of contraception.
2. For female of childbearing potential, acceptable forms of contraception include the following:
a. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
b. Barrier methods containing or used in conjunction with a spermicidal agent, or
c. Surgical sterilization or
d. Practicing sexual abstinence throughout the course of the study.
3. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
a. Postmenopausal with spontaneous amenorrhea for at least one year, or
b. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
c. Total hysterectomy and an absence of bleeding for at least 3 months
4. BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
5. Able to communicate effectively with study personnel
6. No nasal abnormalities
7. Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
8. Willing to provide written informed consent to participate in the study.
9. All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the dose of study medication which will include:
a) A physical examination (clinical examination) with no clinically significant finding
b) Lab results within normal limits or clinically non-significant
10. Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion
11. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
1) History of allergic responses to Antihistamines and steroid or other related drugs.
2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, nasal examination [examination include (1) external nose but not limited to size and shape, obvious swellings or deformity, scars or skin changes and redness or discharge and (2) nasal cavity for but not limited to nasal septum, turbinates, entire nasal cavity for rhinitis, oedematous and inflamed mucosa, polyps or any other abnormalities and presence of any foreign bodies], nasal bone X-ray, Ophthalmic examination, Peak Nasal Inspiratory Flow measurement, gynecological
history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
4) History or presence of bronchial asthma.
5) Use of any hormone replacement therapy within 3 months prior to the dose of study medication.
6) A depot injection or implant of any drug within 3 months prior to the dose of study medication.
7) Use of CYP enzyme inhibitors or inducers within 30 days prior to the dose of study medication
8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9) History of difficulty with donating blood or difficulty in accessibility of veins.
10) A positive hepatitis screen (includes subtypes B & C).
11) A positive test result for HIV antibody and / or syphilis (RPR).
12) Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the dose of study medication.
13) Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to dose of study medication, whichever is greater.
14) Intolerance to venipuncture
15) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteerââ?¬•s participation in this study.
16) Institutionalized volunteers.
17) Use of any prescribed medications within 14 days prior to the dose of study medication.
18) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the dose of study medication.
19) Use of grapefruit and grapefruit containing products within 7 days prior to the dose of study medication.
20) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the dose of study medication.
21) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the dose of study medication.
22) Ingestion of alcohol or other alcohol containing products for two weeks prior to the dose of study medication.
23) Volunteer having any relevant disease including seasonal and perennial allergic rhinitis, asthma during screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate Pharmacokinetic parameters Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and half will be calculated for ALDP 001 & its metabolite. <br/ ><br>2. The safety and tolerability of the subjectsTimepoint: Total 19 venous blood samples (06 mL each) will be collected at pre-dose (0.0 hour) and at 0.0334 (2 min), 0.083 (5 min), 0.167 (10 min), 0.25 (15 <br/ ><br>min), 0.417 (25 min), 0.5 (30 min), 0.75 (45 min), 0.833 (50 min), 1.0, <br/ ><br>2.0, 3.0, 5.0, 7.0, 9.0, 12.0, 24.0, 72.0 and 144.0 hours post dose
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI