Clinical trials: Bioequivalence Study in Healthy Subjects
Gastrointestinal Stromal Tumors, Renal Cell Carcinoma
A Bioequivalence Study of Sunitinib Malate Capsules.
A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of…
- Conditions
- Gastrointestinal Stromal Tumors, Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor
- Trial name
- NCT05800106
- Testing
- Sunitinib malate capsules generic product, Sunitinib malate capsules reference product
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Pregnancy Related, Nausea
Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers
The study aimed for: 1. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and Diclectin…
- Trial name
- NCT05498233
- Testing
- Doxylamine + Pyridoxine
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
- Trial name
- NCT01099709
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy Volunteers
A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers
The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.
- Trial name
- NCT00905814
- Testing
- AG-013736, AG-103736
- Where
- Singapore
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.
- Trial name
- NCT00650364
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteer
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a…
- Trial name
- NCT02486809
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Solid Tumor
An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fasting condition.
- Trial name
- NCT05390944
- Testing
- IMP4297(20mg), IMP4297(10mg)
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233149
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Chemotherapy-Induced Nausea and Vomiting
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
- Trial name
- NCT00971633
- Testing
- Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron), Comparator: Treatment C (Zofran, ondansetron)
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
- Trial name
- NCT03517033
- Testing
- Torrent's Nebivolol Tablets, Forest Pharmaceuticals Inc.'s Bystolic Tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteer
A Study to Assess the Bioequivalence of Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Healthy Chinese Subjects.
To assess the bioequivalence between dapagliflozin/metformin XR FDC tablet and co-administration of dapagliflozin and metformin XR tablets.
- Trial name
- NCT04856007
- Testing
- Dapagliflozin/metformin XR FDC 5/500 mg, Dapagliflozin/metformin XR FDC 10/1000 mg, Dapagliflozin 5 mg + Metformin 500 mg XR
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed…
- Trial name
- NCT00838136
- Testing
- Lamotrigine 25 mg Chewable Tablets, Lamictal® 25 mg Chewable Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Fed
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735344
- Testing
- Lisinopril Tablets 40 mg, Lisinopril
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr.
- Trial name
- NCT01045434
- Testing
- Omeprazole
- Where
- India
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Participants
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
- Trial name
- NCT05048784
- Testing
- Sotorasib
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Amgen
Viral Infection COVID-19
Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
1. Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in…
- Trial name
- NCT06096571
- Testing
- Aterixen
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Volunteer
Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers
- Trial name
- NCT06926387
- Testing
- YHP2407, YHR2502
- Where
- South Korea
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Tablets 1g
The objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent. Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly).
- Trial name
- NCT01767584
- Testing
- Cephalexin 1g tablets
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Adult
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods…
- Trial name
- NCT01506752
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
- Trial name
- NCT00878514
- Testing
- Alprazolam, Xanax
- Where
- Finland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
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