A Bioequivalence Study of Two Formulations of 25 mg Pregabalin Capsules in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- healthy volunteerPregabalin Bioequivalence
- Registration Number
- TCTR20230208004
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 28
1 Thai male or female, age between 18 to 55 years
2 Has body mass index (BMI) between 18.0 to30.0
3 Has been determined healthy by physical examination, assessment of medical history and vital signs or showing no clinically significant abnormalities in the opinion of principal investigator or designated physicians
4 Has normal or acceptable results for all screening tests
5 Has negative result for hepatitis B viral profile
6 Has normal or acceptable report for EKG
7 Male subjects agree to use effective contraceptive from screening visit to the follow-up visit
8 Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing at screening and prior to dosing at period 1 and period 2.
9 Female subjects who is childbearing potential and using effective non-hormonal contraceptive methods or total abstinence from sexual intercourse from screening visit to the follow-up visit
10.Female subject who is non-childbearing potential hysterectomy, both ovaries removed, surgically sterilized or postmenopausal for
11.Non-smokers
12Refrain from using herbal medications, dietary supplements within 14 days before the first administration of study drug. Subjects must agree to refrain from these items until the last collection time-point of period 2
13Subjects must have ended the systematic medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period
14Subject dose not receive Coronavirus Disease-19 vaccine within 14 days before dosing and does not plan to receive COVID-19 vaccine until the follow-up visit
15Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of period 2
16Has ability and intention to comply with the requirements of study and available for the whole study period
17 Willing to participate and voluntarily signed the informed consent form prior to the initiation of any screening or study specific procedure
1 Known hypersensitivity to pregabalin and/or related structure and/or its constituents
2 Has history or concurrent symptoms of cardiovascular, gastrointestinal, hematological disorders, renal and hepatic impairment and/or any disease that may affect the bioavailability of the drug
3 Alcohol abuse or excessive use in the last 12 months
4 Alcohol breath test at screening visit or before admission show alcohol concentration more than 0
5 History of drug abuse or urine sample at screening visit or before admission shows a positive test for Morphine, Marijuana and Methamphetamine
6 Following a special diet
7 A pregnant woman or woman in breast feeding period
8 A woman of childbearing potential and using hormonal contraceptive methods including oral contraceptives, hormone replacement therapy and transdermal contraceptives within 14 days prior to dosing and during the entire period of the study and/or using injected, intrauterine and implanted hormonal methods of contraception within 3 months prior to dosing and during the entire period of the study
9 A participant in any investigation drug study within last 30 days prior to screening
10 Has blood donated within last 2 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood concentration 0-24 hour after dosing pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method safety first doing until follow-up visit Volunteer reported adverse events